Spirometer, Diagnostic
FDA product code BZG · Class II (moderate risk) · 21 CFR 868.1840 · Anesthesiology
228510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Vitalograph (Ireland) , Ltd. 9
- Mir Medical Intl. Research Srl 9
- Sdi Diagnostics, Inc. 8
- Vitalograph , Ltd. 7
- Erich Jaeger, Inc. 6
- Puritan Bennett Corp. 5
- Morgan Scientific, Inc. 5
- Medical Equipment Designs, Inc. 5
- Sensor Medics Corp. 5
- Future Impex Corp. 5
- Welch Allyn, Inc. 4
- Fukuda Denshi USA, Inc. 4
- Carefusion Germany 234 GmbH 4
- Spirometrics, Inc. 4
- Futuremed Div. of Future Impex Corp. 4
- Collins Medical, Inc. 3
- Pulmonx Corporation 3
- Fim Medical 3
- Futuremed America, Inc. 3
- Spirometrics Medical Equipment Co. 3
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251777 | MESI mTABLET SPIROBZG · Traditional | Mesi D.O.O. | 03/02/2026SE |
| K241843 | TD-7301 Spirometer (TD-7301)BZG · Traditional | Gostar Co., Ltd. | 11/20/2024SE |
| K231416 | Air Next (NVD-02)BZG · Traditional | Nuvoair AB | 01/18/2024SE |
| K230501 | Spirobank OxiBZG · Traditional | Mir Medical International Research USA | 12/15/2023SE |
| K230178 | EasyOne Sky SpirometerBZG · Traditional | Ndd Medizintechnik AG | 10/19/2023SE |
| K222525 | Alveoair Digital SpirometerBZG · Traditional | Roundworks Technologies Private Limited | 08/28/2023SE |
| K222443 | Air Smart Extra SpirometerBZG · Traditional | Feellife Health, Inc. | 08/09/2023SE |
| K213754 | SpiroHome Personal, SpiroHome ClinicBZG · Traditional | Inofab Saglik Teknolojileri A.S | 06/12/2023SE |
| K213872 | ComPAS2BZG · Traditional | Morgan Scientific, Inc. | 07/15/2022SE |
| K212938 | Vitalograph Model 6000 AlphaBZG · Traditional | Vitalograph Ireland, Ltd. | 01/26/2022SE |
| K201493 | SpirometerBZG · Traditional | Mehow Innovative, Ltd. | 06/10/2021SE |
| K202837 | GoSpiroBZG · Special | Monitored Therapeutics, Inc. | 12/04/2020SE |
| K201562 | SpirotracBZG · Traditional | Vitalograph Ireland, Ltd. | 10/14/2020SE |
| K201002 | Safey Pocket SpirometerBZG · Traditional | Safey Medical Devices Pvt, Ltd. | 07/30/2020SE |
| K200550 | Vitalograph Model 2120 In2itive eDiaryBZG · Traditional | Vitalograph Ireland, Ltd. | 07/27/2020SE |
| K183089 | Air NextBZG · Traditional | Nuvoair AB | 01/02/2020SE |
| K183479 | Asthma Monitor AM3BZG · Special | Eresearch Technology | 10/03/2019SE |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG · Traditional | Welch Allyn, Inc. | 09/10/2019SE |
| K190568 | ComPAS2 (Computerized Pulmonary Analysis System)BZG · Special | Morgan Scientific, Inc. | 06/06/2019SE |
| K180011 | Pulmonx Chartis Tablet ConsoleBZG · Traditional | Pulmonx Corporation | 07/13/2018SE |
| K163249 | GoSpiroBZG · Traditional | Monitored Therapeutics, Inc. | 03/24/2017SE |
| K161536 | EasyOne Air SpirometerBZG · Traditional | Ndd Medizintechnik AG | 01/05/2017SE |
| K161676 | Q13 Spirolyser®BZG · Traditional | Fim Medical | 10/20/2016SE |
| K160116 | SpiroScoutBZG · Traditional | Ganshorn Medizin Electronic GmbH | 10/07/2016SE |
| K160253 | Vitalograph Model 6300 microBZG · Traditional | Vitalograph (Ireland) , Ltd. | 08/26/2016SE |
| K150515 | IQSense Flow Sensor MouthpieceBZG · Traditional | Sdi Diagnostics, Inc. | 01/12/2016SE |
| K142642 | Vitalograph Model 6600 CompactBZG · Traditional | Vitalograph (Ireland) , Ltd. | 06/30/2015SE |
| K142812 | Vitalograph Model 6800 PneumotracBZG · Traditional | Vitalograph (Ireland) , Ltd. | 06/29/2015SE |
| K120577 | MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DXBZG · Traditional | Medikro OY | 06/24/2015SE |
| K150137 | SpiroThorBZG · Traditional | Cohero Health, LLC | 05/27/2015SE |
| K141793 | Pulmone Miniboxpft 2.0BZG · Traditional | Pulmone Advanced Medical Devices, Ltd. | 03/06/2015SE |
| K141936 | Microblab, MicroloopBZG · Traditional | Carefusion Germany 234 GmbH | 12/29/2014SE |
| K142303 | NeumoFilt Ergo/Neumo Filt BiteOnBZG · Traditional | Medical Respiratory Devices S.L. | 11/20/2014SE |
| K141546 | Vitalograph Model 7000 SpirotracBZG · Traditional | Vitalograph (Ireland) , Ltd. | 09/03/2014SE |
| K133428 | Medikro Nano, Medikro Primo and Medikro ProBZG · Traditional | Medikro OY | 05/21/2014SE |
| K133722 | Asthma Monitor AM3BZG · Traditional | Eresearch Technology | 05/08/2014SE |
| K130322 | SPM-300BZG · Traditional | Bionet Co., Ltd. | 11/15/2013SE |
| K130784 | SpirotelBZG · Special | Mir Medical Intl. Research Srl | 10/30/2013SE |
| K123896 | CCS-200 SpirometerBZG · Traditional | Benson Medical Instruments Co. | 09/10/2013SE |
| K122384 | MinispirBZG · Special | Mir Medical Intl. Research Srl | 10/04/2012SE |
| K120880 | OrbitBZG · Special | National Biomedical, LLC Dba Qrs Diagnostic | 04/19/2012SE |
| K113096 | Micro IBZG · Traditional | Carefusion Germany 234 GmbH | 04/13/2012SE |
| K103530 | SpirodocBZG · Traditional | Medical International Research USA, Inc. | 11/21/2011SE |
| K111764 | Chartis ConsoleBZG · Special | Pulmonx, Inc. | 11/10/2011SE |
| K103575 | Spiro PDBZG · Traditional | Pmd Healthcare | 11/09/2011SE |
| K111587 | Alerkan Spirometry FilterBZG · Traditional | Alerkan, Ltd. | 10/20/2011SE |
| K100928 | Micro Diary SpirometerBZG · Traditional | Viasys Respiratory Care, Inc. | 03/07/2011SE |
| K101873 | Masterscreen IosBZG · Traditional | Carefusion Germany 234 GmbH | 02/10/2011SE |
| K100687 | Vitalograph Hand Held Spirometer, Model 2120BZG · Traditional | Vitalograph (Ireland) , Ltd. | 10/16/2010SE |
| K092813 | Astrasonic Spirometer, Model 29-8000BZG · Traditional | Sdi Diagnostics, Inc. | 07/16/2010SE |
| K093174 | SpiropalmBZG · Traditional | Cosmed Srl | 02/26/2010SE |
| K092890 | Asthma Monitor AM3BZG · Special | Carefusion Germany 234 GmbH | 01/13/2010SE |
| K090646 | Cardiotech Spirometry System, Model GT-105BZG · Traditional | Chest M.I., Inc. | 07/23/2009SE |
| K083199 | Chartis ConsoleBZG · Traditional | Pulmonx, Inc. | 06/25/2009SE |
| K090034 | Easy On-Pc SpirometerBZG · Traditional | Ndd Medizitechnik AG | 06/02/2009SE |
| K090486 | Asthma Monitor Model, AM1BZG · Special | Cardinal Health Germany 234 GmbH | 05/06/2009SE |
| K082478 | Welch Allyn Cardioperfect Workstation Software (CPWS) V 1.62BZG · Abbreviated | Welch Allyn, Inc. | 03/09/2009SE |
| K083233 | The PFT FilterBZG · Traditional | Pulmonary Filtration Technologies, LLC | 03/02/2009SE |
| K083879 | Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-By-Breath…BZG · Traditional | Innovision A/S | 02/23/2009SE |
| K080921 | Spiro-Master PC-10 Spirometry SystemBZG · Traditional | Chest M.I., Inc. | 01/21/2009SE |
| K082766 | Modification to Minispir, Spirolab IIIBZG · Special | Mir Medical Intl. Research Srl | 12/17/2008SE |
| K073155 | Vitalograph Model 4000 (ASMA-1 and COPD-6)BZG · Traditional | Vitalograph (Ireland) , Ltd. | 06/04/2008SE |
| K072722 | Meddorna Wireless PRN Spirometer 100BZG · Traditional | Meddorna, LLC | 04/24/2008SE |
| K072979 | Spirobank GBZG · Special | Mir Medical Intl. Research Srl | 12/26/2007SE |
| K061571 | Astra 300BZG · Traditional | Sdi Diagnostics, Inc. | 01/31/2007SE |
| K062913 | Astraguard Pulmonary Function FilterBZG · Traditional | Sdi Diagnostics, Inc. | 01/26/2007SE |
| K061283 | PulmolifeBZG · Traditional | Micro Medical, Ltd. | 12/14/2006SE |
| K061875 | Minispir; Spirolab IIIBZG · Traditional | Mir Medical Intl. Research Srl | 12/11/2006SE |
| K061712 | Spirobank IIBZG · Traditional | Mir Medical Intl. Research Srl | 12/01/2006SE |
| K052140 | Spirolab, Spirolab IIBZG · Traditional | Mir Medical Intl. Research Srl | 03/16/2006SE |
| K052176 | Flowhandy ZAN100 UsbBZG · Traditional | Zan Messgerate GmbH | 01/12/2006SE |
| K051572 | Koko LegendBZG · Special | Pulmonary Data Services, Inc. | 11/17/2005SE |
| K052158 | Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareBZG · Special | Welch Allyn, Inc. | 09/08/2005SE |
| K051712 | Model 2800 PFT FilterBZG · Traditional | Air Safety, Ltd. | 09/01/2005SE |
| K042758 | Polytech Pulmonary Function FilterBZG · Traditional | Polytechnic Resources, Inc. | 08/29/2005SE |
| K043528 | SpirotelBZG · Traditional | Mir Medical Intl. Research Srl | 07/19/2005SE |
| K050424 | Ergofilter Spi Accessory to Spirolyser SPL-50BZG · Traditional | Fim Medical | 06/23/2005SE |
| K042595 | Spiro'AirBZG · Traditional | Morgan Scientific, Inc. | 05/04/2005SE |
| K042058 | Oneflow FVC, Oneflow FVC (Kit), Oneflow FVC ScreenBZG · Traditional | Clement Clarke Intl., Ltd. | 03/23/2005SE |
| K033518 | Lotus Pulmonary Function Filter, Models CPF 101, CPF 102, CPF 103BZG · Traditional | Custom Plastic Products | 03/10/2004SE |
| K033939 | Flosense II, Model 29-8040BZG · Traditional | Sdi Diagnostics, Inc. | 01/30/2004SE |
| K031643 | Spirotel, Model 29-1020BZG · Traditional | Sdi Diagnostics, Inc. | 12/09/2003SE |
| K031102 | Microlab SpirometerBZG · Traditional | Micro Direct, Inc. | 12/01/2003SE |
| K030917 | Gem; Hawk; Eagle; Models 004110, 0044120, 004130BZG · Special | Collins Medical, Inc. | 05/14/2003SE |
| K020102 | Iqteq SpirometerBZG · Traditional | Iqteq Development | 03/21/2003SE |
| K030464 | Gem, Model 004110BZG · Special | Collins Medical, Inc. | 03/14/2003SE |
| K023225 | Puritan Bennett Dataflow Data Management SoftwareBZG · Abbreviated | Puritan Bennett Corp. | 12/18/2002SE |
| K021200 | CompasBZG · Traditional | Morgan Scientific, Inc. | 10/18/2002SE |
| K022276 | KokomateBZG · Abbreviated | Ferraris Respiratory, Inc. | 10/04/2002SE |
| K022103 | Puritan-Bennett 700 Renaissance II Spirometry SystemBZG · Special | Puritan Bennett Corp. | 09/27/2002SE |
| K020280 | Pulmolab EX671 Exercise Testing SystemBZG · Traditional | Morgan Medical , Ltd. | 09/24/2002SE |
| K020004 | Clindatalink Version 1.0 for SpirometryBZG · Traditional | Compleware Corp. | 07/24/2002SE |
| K013123 | EMS Pulmonary Function Testing FilterBZG · Traditional | Engineered Medical Systems | 03/14/2002SE |
| K010761 | SPL-50 SpirolyserBZG · Traditional | Fim Medical | 03/05/2002SE |
| K013812 | Spirolab II, Model 29BZG · Traditional | Sdi Diagnostics, Inc. | 02/11/2002SE |
| K013752 | Compas AS (Computerized Pulmonary Analysis System)BZG · Traditional | Morgan Scientific, Inc. | 01/30/2002SE |
| K011470 | Sdi SB Office, Model 29-BZG · Traditional | Sdi Diagnostics, Inc. | 10/12/2001SE |
| K001528 | PC Flow +BZG · Abbreviated | Spirometrics Medical Equipment Co. | 01/18/2001SE |
| K001278 | Sensaire Diagnostic SpirometerBZG · Traditional | Qrs Diagnostic, LLC | 11/29/2000SE |
| K002499 | Brentwood Iqmark Digital Spirometer (Includes Disposable Pneumotach Mouthpieces and…BZG · Traditional | Brentwood Medical Technology Corp. | 11/08/2000SE |
| K000599 | Vitalograph Base StationBZG · Traditional | Vitalograph, Inc. | 09/08/2000SE |
| K993921 | NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model…BZG · Traditional | Ndd Medical Technologies | 05/23/2000SE |
| K992823 | Spirovit SP-2, Pneumocheck IIBZG · Traditional | Schiller AG | 05/12/2000SE |
| K992743 | Collins CPLBZG · Special | Collins Medical, Inc. | 09/13/1999SE |
| K984031 | Spirovit, Model SP-250BZG · Traditional | Schiller AG | 04/30/1999SE |
| K983909 | Mir Spirobank SpirometerBZG · Traditional | Mir Medical Intl. Research Srl | 12/21/1998SE |
| K971336 | Caird Technology SpirometerBZG · Traditional | Caird Technology | 12/01/1998SE |
| K982956 | Flowmate II Plus, Model #4000BZG · Traditional | Spirometrics Medical Equipment Co. | 11/24/1998SE |
| K973138 | SpirocardBZG · Traditional | Qrs Diagnostic, LLC | 10/28/1998SE |
| K980876 | Asthma Monitor AM2BZG · Traditional | Erich Jaeger GmbH & Co. KG | 08/14/1998SE |
| K973456 | Spirobank Portable PC Based SpirometerBZG · Traditional | Futuremed America, Inc. | 07/22/1998SE |
| K980441 | Spirometer Model NPB-500BZG · Traditional | Nellcor Puritan Bennett, Inc. | 04/30/1998SE |
| K965042 | Microdl Diarycard SpirometerBZG · Traditional | Micro Direct, Inc. | 06/17/1997SE |
| K963131 | Graseby Andersen's, Integrity S700BZG · Traditional | Graseby Andersen | 02/14/1997SE |
| K963035 | Micro SpirometerBZG · Traditional | Micro Direct, Inc. | 11/01/1996SE |
| K960078 | Asthma MonitorBZG · Traditional | Erich Jaeger, Inc. | 09/20/1996SE |
| K953948 | Spirovision Sv-Iii PC Based Spirometer Kit MicroBZG · Traditional | Futuremed America, Inc. | 06/25/1996SE |
| K954759 | Flowmate LteBZG · Traditional | Spirometrics Medical Equipment Co. | 04/12/1996SE |
| K951718 | Hm-SpiroBZG · Traditional | Hill-Med, Inc. | 12/20/1995SE |
| K954140 | Masterscreen IosBZG · Traditional | Erich Jaeger GmbH & Co. KG | 12/14/1995SE |
| K950223 | Discovery Graphic Portable SpirometerBZG · Traditional | Futuremed America, Inc. | 11/17/1995SE |
| K951227 | DX1BZG · Traditional | Creative Biomedics, Inc. | 08/11/1995SE |
| K946075 | Vitalograph Model 2120BZG · Traditional | Vitalograph, Inc. | 08/04/1995SE |
| K946322 | Polygram SoftwareBZG · Traditional | Synectics Medical, Inc. | 07/07/1995SE |
| K951367 | Porta-Screen SpirometerBZG · Traditional | S & M Instrument Co. | 04/14/1995SE |
| K943546 | Fukuda Sangyo Model Spiroanalyzer ST-180BZG · Traditional | Spirosoft Northamerica, Inc. | 02/23/1995SE |
| K944762 | Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB Data…BZG · Traditional | Puritan Bennett Corp. | 12/13/1994SE |
| K944175 | Adam Shell Thermocouple AssemblyBZG · Traditional | Pro-Tech Services, Inc. | 10/14/1994SE |
| K942779 | Disposable Bacteriological FilterBZG · Traditional | Vitalograph, Inc. | 07/13/1994SE |
| K932936 | L.A.P. II Spriometry SystemBZG · Traditional | Allied Healthcare Products, Inc. | 02/10/1994SE |
| K925459 | Gs-Modular (Gold Standard - Modular)BZG · Traditional | Warren E. Collins, Inc. | 02/04/1994SE |
| K923988 | Sensormedics Model 2200 Pulmonary Function LabsBZG · Traditional | Sensor Medics Corp. | 10/21/1993SE |
| K925085 | Escort SpirometerBZG · Traditional | Vitalograph , Ltd. | 08/12/1993SE |
| K923989 | Sensormedics Model 6200 Autobox DLBZG · Traditional | Sensor Medics Corp. | 08/09/1993SE |
| K924413 | FlowscanBZG · Traditional | Electrocaine Medical System | 05/06/1993SE |
| K921513 | Spirolite Model MSC-201 SpirometerBZG · Traditional | Medical Systems Corp. | 01/27/1993SE |
| K922428 | Fukuda Denshi Model Spirosift SP-5000BZG · Traditional | Fukuda Denshi USA, Inc. | 01/15/1993SE |
| K920877 | The Keystone SystemBZG · Traditional | S & M Instrument Co. | 12/23/1992SE |
| K920111 | Sensormedics Model 2130 Spieometry SystemBZG · Traditional | Sensor Medics Corp. | 10/26/1992SE |
| K915451 | Multispiro-SxBZG · Traditional | Multispiro, Inc. | 07/02/1992SE |
| K914272 | Koko SpirometerBZG · Traditional | Ferraris Respiratory, Inc. | 07/02/1992SE |
| K913396 | Cannula Style ThermocouplesBZG · Traditional | Pro-Tech, Inc. | 05/22/1992SE |
| K913395 | EZ-1 System Respiratory Effort SensorsBZG · Traditional | Pro-Tech, Inc. | 05/20/1992SE |
| K914205 | PFF-1BZG · Traditional | Cybermedic, Inc. | 05/01/1992SE |
| K920246 | Sensormedics Model 922 SpirometerBZG · Traditional | Sensor Medics Corp. | 04/08/1992SE |
| K914219 | Airway ThermistorBZG · Traditional | Synectics-Dantec | 02/26/1992SE |
| K914085 | HMS-5000BZG · Traditional | Vitalog Monitoring,Inc. | 11/19/1991SE |
| K912412 | Vitalograph Spirotrac IIIBZG · Traditional | Vitalograph , Ltd. | 10/15/1991SE |
| K904625 | Synectics Liberty System, PC Polygraf and PolygramBZG · Traditional | Synectics-Dantec | 08/20/1991SE |
| K910950 | HMS-4000 Multichannel Physio Monit Syst, ModifiedBZG · Traditional | Vitalog Monitoring,Inc. | 08/02/1991SE |
| K912234 | Somniprobe(R) Model Number 10093, ModificationBZG · Traditional | Somnitec, Inc. | 07/22/1991SE |
| K904200 | Spirosift 500ABZG · Traditional | Fukuda Denshi USA, Inc. | 05/22/1991SE |
| K910452 | Respi-Pak Rt-PakBZG · Traditional | Cns, Inc. | 04/16/1991SE |
| K904118 | Somniprobe II Nasal and Buccal Airflow Mon. Syst.BZG · Traditional | Dawn Medical | 02/25/1991SE |
| K904117 | Somnigauge Thoracic/Abdominal Expansion Mon. Syst.BZG · Traditional | Dawn Medical | 02/25/1991SE |
| K904947 | PM2002 CC, Aristocrat and Aristocrat DeluxeBZG · Traditional | Planmeca USA, Inc. | 01/30/1991SE |
| K900331 | Tuba TM (Transit-Time Ultrasonic Breath Analyzer)BZG · Traditional | Ghg Medizin-Elektronik AG | 09/04/1990SE |
| K901308 | Spiro Analyzer Model ST 250BZG · Traditional | Futuremed Div. of Future Impex Corp. | 07/23/1990SE |
| K900391 | Fukuda Denshi Model Spirosift 3000BZG · Traditional | Fukuda Denshi USA, Inc. | 04/10/1990SE |
| K901057 | Spirometrics Model 2600 Miro SpirometerBZG · Traditional | Spirometrics, Inc. | 04/03/1990SE |
| K900673 | Serial FlowBZG · Traditional | Spirometrics, Inc. | 04/03/1990SE |
| K896300 | LDW Spirometry SystemBZG · Traditional | Lanpher Diagnostic Workstations, Inc. | 04/03/1990SE |
| K896924 | Spiroscan 4000BZG · Traditional | Brentwood Instruments, Inc. | 03/01/1990SE |
| K895414 | Multimed (TM) Pulmonary Function Testing SystemBZG · Traditional | Integrated Medical Systems, Inc. | 02/12/1990SE |
| K895953 | Wright Ventilometer VM-1BZG · Traditional | Clement Clarke, Inc. | 02/02/1990SE |
| K897094 | Modified Spiroscan 1000BZG · Traditional | Fukuda Denshi USA, Inc. | 01/12/1990SE |
| K896121 | Schiller Model SP-200 Spirovit(Tm)BZG · Traditional | Schiller America, Inc. | 01/09/1990SE |
| K896120 | Schiller Model SP-100 Spirovit(Tm)BZG · Traditional | Schiller America, Inc. | 01/09/1990SE |
| K894556 | SpiroteqBZG · Traditional | System Analysis Corp. | 01/09/1990SE |
| K895375 | MultispiroBZG · Traditional | Medical Equipment Designs, Inc. | 11/27/1989SE |
| K895253 | Pneumocheck W/Printer/Charger and AccessoriesBZG · Traditional | Welch Allyn, Inc. | 11/02/1989SE |
| K894997 | Presto Diagnostic SpirometerBZG · Traditional | Tamarac Systems Corp. | 10/30/1989SE |
| K894680 | RS232 Flow Sensor and Software PackageBZG · Traditional | Tamarac Systems Corp. | 10/23/1989SE |
| K891672 | Pul-Tron 100K Professional SpirometerBZG · Traditional | Advanced Medical Systems, Inc. | 06/16/1989SE |
| K890522 | Puritan Bennett PB900A Diagnostic SpirometerBZG · Traditional | Puritan Bennett Corp. | 04/21/1989SE |
| K881402 | 629V Spirometer, Pulmonary Function AnalyzerBZG · Traditional | American Electromedics Corp. | 09/26/1988SE |
| K873562 | Vitalograph-AlphaBZG · Traditional | Vitalograph , Ltd. | 08/29/1988SE |
| K873817 | Spiro Analyzer ST-300BZG · Traditional | Futuremed Div. of Future Impex Corp. | 12/02/1987SE |
| K863134 | Multispiro SA/100BZG · Traditional | Biotrine Corp. | 12/15/1986SE |
| K863656 | Salter Voluchek 6600BZG · Traditional | Salter Labs | 10/06/1986SE |
| K862023 | Spiromate AS-600BZG · Traditional | Riko Medical & Scientific Instrument Corp. | 06/17/1986SE |
| K861227 | Collins Pneumotach PFT SystemBZG · Traditional | Warren E. Collins, Inc. | 06/05/1986SE |
| K860522 | Spirometer, Model TS-1000, Part No. SLZ7504BZG · Traditional | Teledyne Avionics Div. of Teledyne | 03/03/1986SE |
| K853409 | ScreenmateBZG · Traditional | Erich Jaeger, Inc. | 02/05/1986SE |
| K854403 | Model 2120 SpiroscreenBZG · Traditional | Gould, Inc. | 01/14/1986SE |
| K854526 | Vitalograph CompactBZG · Traditional | Vitalograph , Ltd. | 12/24/1985SE |
| K854062 | Pall Pulmonary Function FilterBZG · Traditional | Pall Biomedical Products Co. | 11/07/1985SE |
| K852092 | PB900 PB910 Diagnostic SpirometerBZG · Traditional | Puritan Bennett Corp. | 07/30/1985SE |
| K852677 | MTS4400 Metabolic & Respiratory Testing SystemBZG · Traditional | Alpha Technologies, Inc. | 07/19/1985SE |
| K852307 | Pulmonary Test System FUDAC-30BZG · Traditional | Futuremed Div. of Future Impex Corp. | 07/05/1985SE |
| K852337 | PneumoscopeBZG · Traditional | Erich Jaeger, Inc. | 07/01/1985SE |
| K851135 | Spiro ScanBZG · Traditional | Brentwood Instruments, Inc. | 07/01/1985SE |
| K852308 | ST-460 Spiro Analyzer SpirometerBZG · Traditional | Futuremed Div. of Future Impex Corp. | 06/24/1985SE |
| K851620 | Spiromed 2BZG · Traditional | Draeger Medical, Inc. | 05/10/1985SE |
| K851277 | Microspiro-SdsBZG · Traditional | Medical Equipment Designs, Inc. | 04/19/1985SE |
| K843841 | Ergo-OxyscreenBZG · Traditional | Erich Jaeger, Inc. | 12/27/1984SE |
| K844333 | Spirometrics 2451 & Smi IBZG · Traditional | Spirometrics, Inc. | 11/20/1984SE |
| K844226 | B-1000BZG · Traditional | Biotrine Corp. | 11/20/1984SE |
| K843996 | Turboaire Challanger Environmental Air ControllerBZG · Traditional | Equilibrated Bio Systems, Inc. | 11/20/1984SE |
| K843984 | PM-80 PulmotesterBZG · Traditional | Future Impex Corp. | 10/24/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0324-2025 Class II | Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic…There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system… | Baxter Healthcare Corporation | 10/11/2024Open, Classified |