Calculator, Pulmonary Function Data
FDA product code BZC · Class II (moderate risk) · 21 CFR 868.1880 · Anesthesiology
90510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Erich Jaeger, Inc. 7
- Warren E. Collins, Inc. 4
- Novametrix Medical Systems, Inc. 4
- Vyaire Medical 3
- Cosmed Srl 3
- Cardio Pulmonary Instruments 3
- Pulmonary Testing Systems 3
- P.K. Morgan , Ltd. 3
- Cybermedic, Inc. 3
- Medical Graphics Corp. 2
- Viasys Healthcare GmbH 2
- Creative Biomedics, Inc. 2
- Carefusion Germany 234 GmbH 2
- Pulmone Advanced Medical Devices, Ltd. 2
- Cavitron Corp. 2
- Sensor Medics Corp. 2
- Infrasonics Corp. 2
- Spital Medical, Inc. 1
- Puritan Bennett Corp. 1
- Vitalograph , Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240293 | STSBZC · Traditional | Techbopulm, Ltd. | 09/17/2024SE |
| K183567 | Vyntus/SentrySuite Product LineBZC · Traditional | Vyaire Medical | 08/23/2019SE |
| K190853 | Vyntus BODYBZC · Traditional | Vyaire Medical, Inc. | 08/16/2019SE |
| K181524 | Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART…BZC · Traditional | Vyaire Medical, Inc. | 11/30/2018SE |
| K162515 | COSMED K5 Wearable Metabolic TechnologyBZC · Traditional | Cosmed Srl | 06/20/2017SE |
| K161295 | MiniBox +BZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 10/21/2016SE |
| K150810 | Vyntus / SentrySuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/14/2015SE |
| K133925 | Vyntus/ Sentrysuite Product LineBZC · Traditional | Carefusion Germany 234 GmbH | 08/22/2014SE |
| K133051 | Pulmone Minibox PFT TMBZC · Traditional | Pulmone Advanced Medical Devices, Ltd. | 05/02/2014SE |
| K102047 | Lci Option for InnocorBZC · Traditional | Innovision A/S | 11/01/2011SE |
| K072323 | Masterscreen & Oxycon CPXBZC · Special | Viasys Healthcare GmbH | 10/10/2007SE |
| K052328 | Zan Lung-Function LabBZC · Traditional | Zan Messgerate GmbH | 12/22/2005SE |
| K040698 | Masterscreen CPX and Oxycon CPXBZC · Special | Viasys Healthcare GmbH | 04/07/2004SE |
| K023120 | Oxycon MobileBZC · Traditional | Erich Jaeger GmbH | 11/12/2003SE |
| K011344 | Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400BZC · Abbreviated | Collins Medical, Inc. | 05/17/2002SE |
| K001631 | Cortex MetamaxBZC · Traditional | Cortex Biophysik GmbH | 02/22/2001SE |
| K001174 | Cosmed QuarkBZC · Traditional | Cosmed Srl | 01/11/2001SE |
| K001502 | Aerosol Provocation System Aps Pro, Model Aps ProBZC · Special | Erich Jaeger GmbH | 07/12/2000SE |
| K992214 | Oxycon ProBZC · Traditional | Erich Jaeger B.V. | 02/22/2000SE |
| K982499 | Cosmo Plus with Nico, Model 8200BZC · Traditional | Novametrix Medical Systems, Inc. | 10/16/1998SE |
| K982487 | CPT, Inc. Meteor Hand Held Respiratory Mechanics Monitor Meteor 100, CPT, Inc. Meteor…BZC · Traditional | Cardiopulmonary Technologies, Inc. | 10/14/1998SE |
| K970840 | Intelliflow Respiratory AnalyzerBZC · Traditional | Simtec, Inc. | 11/26/1997SE |
| K963373 | Cosmed K4BZC · Traditional | Cosmed Srl | 09/10/1997SE |
| K964360 | Vent(Ventcheck) Handheld Respiratory/Mechanics Monitor Model 101BZC · Traditional | Novametrix Medical Systems, Inc. | 04/04/1997SE |
| K954730 | Benchmark Transfer TestBZC · Traditional | P.K. Morgan , Ltd. | 04/01/1997SE |
| K964939 | The Portable Family - Medi-Facts DX1 Portable Lite and DX1 Portable PlusBZC · Traditional | Creative Biomedics, Inc. | 03/06/1997SE |
| K963380 | Co 2 Smo PlusBZC · Traditional | Novametrix Medical Systems, Inc. | 01/22/1997SE |
| K960121 | Autolink Body PlethysmographBZC · Traditional | P.K. Morgan , Ltd. | 01/09/1997SE |
| K953990 | Transflow TestBZC · Traditional | P.K. Morgan , Ltd. | 12/09/1996SE |
| K960831 | Ventrak RMMS 1550BZC · Traditional | Novametrix Medical Systems, Inc. | 05/29/1996SE |
| K952542 | Ackrad Esophageal Balloon Catheter SetBZC · Traditional | Ackrad Laboratories | 04/23/1996SE |
| K946077 | Directional Control Valves Inflatable Balloon-Type and ControllersBZC · Traditional | Hans Rudolph, Inc. | 09/15/1995SE |
| K951157 | DX1-PORTABLEBZC · Traditional | Creative Biomedics, Inc. | 08/11/1995SE |
| K941843 | MMS-2400BZC · Traditional | Parvo Medics, Inc. | 06/16/1995SE |
| K945213 | Teen 100BZC · Traditional | Aerosport, Inc. | 05/25/1995SE |
| K942864 | Lung DiffusionBZC · Traditional | Nordan Smith Welding Supplies | 03/03/1995SE |
| K935309 | Lung DiffusionBZC · Traditional | Acetylene Gas Co. | 09/27/1994SE |
| K921306 | Argis Pulmonary Function Testing SystemBZC · Traditional | Med Science | 06/25/1993SE |
| K915833 | Sensormedics Model 2600 Pediatric Pulmoonary CartBZC · Traditional | Sensor Medics Corp. | 12/02/1992SE |
| K915686 | Model 2900 Metabolic Measurement CartBZC · Traditional | Sensor Medics Corp. | 12/01/1992SE |
| K913681 | Multispiro-BreezeBZC · Traditional | Multispiro, Inc. | 07/02/1992SE |
| K905480 | SpiroscopeBZC · Traditional | Grandcor Medical Systems | 05/06/1991SE |
| K900696 | Biore CP-100 Cardiopulmonary MonitorBZC · Traditional | Bicore Monitoring Systems | 11/29/1990SE |
| K895963 | Modified Star CalcBZC · Traditional | Infrasonics Corp. | 03/16/1990SE |
| K893845 | Peds Water Filled Catheter/Transducer SystemBZC · Traditional | Medical Associated Services, Inc. | 10/27/1989SE |
| K894839 | OS-1 Occlusion System - 1BZC · Traditional | Medical, Inc. | 10/24/1989SE |
| K892670 | Physio-Dyne Easi (Easy Analog Sampling Interface)BZC · Traditional | Physio-Dyne Instrument Corp. | 09/22/1989SE |
| K892121 | Spiro-Link Real Time Spirometry SystemBZC · Traditional | Biocom Intl., Inc. | 06/16/1989SE |
| K881235 | Q-Plex 1BZC · Traditional | Quinton, Inc. | 03/31/1989SE |
| K883732 | Argis Pulmonary Function Testing SystemBZC · Traditional | Advanced Signal Processing, Inc. | 03/09/1989SE |
| K875027 | Star CalcBZC · Traditional | Infrasonics Corp. | 08/16/1988SE |
| K861418 | SpinnakerBZC · Traditional | Cybermedic, Inc. | 05/09/1986SE |
| K860844 | Vista Interface SysstemBZC · Traditional | Vacumetrics, Inc. | 04/02/1986SE |
| K854626 | Compumed Pulmonary Function Analyzer Model 307BBZC · Traditional | Compumed, Inc. | 02/28/1986SE |
| K853443 | Alveo-Diffusion TestBZC · Traditional | Erich Jaeger, Inc. | 02/21/1986SE |
| K855070 | Spirometer Model TS-200 SLZ 7541BZC · Traditional | Teledyne Avionics Div. of Teledyne | 01/30/1986SE |
| K852909 | MVP - 6000BZC · Traditional | Waters Instruments, Inc. | 11/14/1985SE |
| K851805 | LPA-3 PrinterBZC · Traditional | Life Products, Inc. | 07/08/1985SE |
| K843860 | OxyscreenBZC · Traditional | Erich Jaeger, Inc. | 12/27/1984SE |
| K843852 | Apta-BronchoscreenBZC · Traditional | Erich Jaeger, Inc. | 11/01/1984SE |
| K843848 | Aw TestBZC · Traditional | Erich Jaeger, Inc. | 11/01/1984SE |
| K843849 | PneumoscreenBZC · Traditional | Erich Jaeger, Inc. | 10/16/1984SE |
| K842760 | Lung Analyzer CM-310BZC · Traditional | Cybermedic, Inc. | 07/26/1984SE |
| K840711 | Pulmonary Function SYS-3000BZC · Traditional | Med-Science Electronics, Inc. | 04/02/1984SE |
| K831778 | Rs-Residual Volume SystemBZC · Traditional | Warren E. Collins, Inc. | 08/31/1983SE |
| K831777 | Collins DSBZC · Traditional | Warren E. Collins, Inc. | 08/31/1983SE |
| K831779 | Collins Eagle IIBZC · Traditional | Warren E. Collins, Inc. | 08/26/1983SE |
| K830954 | Acoh Wellness TesterBZC · Traditional | Bradley, Campbell & Carney | 06/10/1983SE |
| K822986 | Pulmonary Function Lab System 1070BZC · Traditional | Medical Graphics Corp. | 11/16/1982SE |
| K812001 | OscillaireBZC · Traditional | Jones Medical Instrument Co. | 08/20/1981SE |
| K810751 | PDS Cardiac Calc. Softw. Progr. #A3604AFBZC · Traditional | General Electric Co. | 04/10/1981SE |
| K802920 | Inspiron Pulmonary Function AnalyzerBZC · Traditional | C.R. Bard, Inc. | 02/23/1981SE |
| K810243 | System 86 Computerized Lung Vol. SpiromeBZC · Traditional | Cardio Pulmonary Instruments | 02/12/1981SE |
| K810196 | System 84 Computerized Lung Vol. SpiromBZC · Traditional | Cardio Pulmonary Instruments | 02/05/1981SE |
| K803255 | Automated Pulmonary Function LaboratoryBZC · Traditional | Cardio Pulmonary Instruments | 01/28/1981SE |
| K802928 | Spirometric Computer #SC-10BZC · Traditional | Cavitron Corp. | 12/17/1980SE |
| K802116 | Anesthesia Gas MachineBZC · Traditional | Puritan Bennett Corp. | 10/03/1980SE |
| K801920 | System 80 Computerized SpirometerBZC · Traditional | Pulmonary Testing Systems | 10/03/1980SE |
| K801919 | System 88 Computerized Diffusion AnalyBZC · Traditional | Pulmonary Testing Systems | 10/03/1980SE |
| K801918 | System 82 Computerized Lung Vo. SpiroBZC · Traditional | Pulmonary Testing Systems | 10/03/1980SE |
| K801497 | Infant Ventilatory Measurement SystemBZC · Traditional | Medical Graphics Corp. | 10/03/1980SE |
| K801597 | PFT CalibratorBZC · Traditional | Spital Medical, Inc. | 08/04/1980SE |
| K801526 | Surveyor I, Respiratory Computer SystemBZC · Traditional | The Devilbiss Co. | 07/21/1980SE |
| K801088 | F.R.C. ApparatusBZC · Traditional | Hogan/Cologne Ent. | 06/17/1980SE |
| K800547 | Medistor III Lung AnalyzerBZC · Traditional | Cybermedic, Inc. | 03/25/1980SE |
| K791503 | Vitalograph Function AnalyzerBZC · Traditional | Vitalograph , Ltd. | 08/16/1979SE |
| K790185 | Model V 4207 Integrating Plug-InBZC · Traditional | Electronics For Medicine, Inc. | 02/16/1979SE |
| K780328 | Pulmonary Function Tester, ComputerizedBZC · Traditional | Warren E. Collins, Inc. | 03/14/1978SE |
| K780322 | Analyzer, Pulmonary FunctionBZC · Traditional | Hospal Medical Corp. | 03/14/1978SE |
| K770532 | PC-30 Pulmonary ComputerBZC · Traditional | Cavitron Corp. | 04/05/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1730-2024 Class I | Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The…Potential of the nozzle separating during patient use. | Vyaire Medical, Inc. | 04/08/2024Open, Classified |
| Z-2769-2016 Class II | Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive…The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device… | Innovision A/S | 05/13/2016Terminated |
| Z-1291-2010 | REFURBISHED TIDALWAVE SP 710, REFURBISHED, Respironics/Philips product. Intended use of…Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain… | Philips Healthcare Inc. | 11/19/2009Terminated |
| Z-1275-2010 | Spanish 100-120V Cosmo Plus 8100, Respironics/Philips product. Used to provide…Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain… | Philips Healthcare Inc. | 11/19/2009Terminated |
| Z-1274-2010 | Resp Profile Monitor, 8100 Cosmo+, Respironics/Philips product. Used to provide…Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain… | Philips Healthcare Inc. | 11/19/2009Terminated |