Recorder, Paper Chart
FDA product code DSF · Class I (low risk) · 21 CFR 870.2810 · Cardiovascular
87510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Honeywell, Inc. 6
- Hewlett-Packard Co. 5
- Edentec Corp. 4
- Physio-Control Corp. 3
- Ge Medical Systems Information Technologies 3
- Litton Medical Electronics 3
- Eaton Medical Group 3
- Datascope Corp. 2
- Air-Shields, Inc. 2
- Astro-Med, Inc. 2
- Fukuda Denshi USA, Inc. 2
- Nihon Kohden America, Inc. 2
- C-V Monitors Corp. 2
- Siemens Medical Solutions USA, Inc. 2
- Siemens Corp. 2
- Cardio Kinetics, Inc. 2
- Medasonics, Inc. 2
- Novametrix Medical Systems, Inc. 2
- American Edwards Laboratories 2
- Gri Medical Products, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K910871 | Edentec Digital Charter Model 3710DSF · Traditional | Edentec Corp. | 08/29/1991SE |
| K912929 | Dash IVDSF · Traditional | Astro-Med, Inc. | 08/13/1991SE |
| K905856 | Model 556 MonitorDSF · Traditional | Ge Medical Systems Information Technologies | 01/11/1991SE |
| K902586 | Gri Lasergraph(Tm) ECG PaperDSF · Traditional | Gri Medical Products, Inc. | 06/22/1990SE |
| K902230 | Colorado Color Imaging RecorderDSF · Traditional | Honeywell, Inc. | 06/19/1990SE |
| K901385 | Gabriel Medical CLS Thermal RecorderDSF · Traditional | Gabriel Medical, Inc. | 05/09/1990SE |
| K895111 | Type 9541 Recorder, Paper ChartDSF · Traditional | S & W Medico Teknik | 01/26/1990SE |
| K894922 | WR3500 and WR3600 Series RecordersDSF · Traditional | Western Graphtec | 01/26/1990SE |
| K894736 | MT96000 Paper Chart RecorderDSF · Traditional | Astro-Med, Inc. | 12/13/1989SE |
| K894607 | PAQ10 Paper Chart RecorderDSF · Traditional | Protocol Systems, Inc. | 10/26/1989SE |
| K893561 | Edentrace 670 System Multichannel Recorder W/Oxim.DSF · Traditional | Edentec Corp. | 08/25/1989SE |
| K885058 | Cardiocap(Tm) DR-104 ReporterDSF · Traditional | Datex Division Instrumentarium Corp. | 07/14/1989SE |
| K890711 | Dual Graph (TM) Recorder-MonitorDSF · Traditional | Somatics, Inc. | 06/02/1989SE |
| K884897 | Four-Channel/Eight-Channel Thermal Array RecorderDSF · Traditional | Mennen Medical, Inc. | 03/09/1989SE |
| K890142 | A10 Ultrascope RecorderDSF · Traditional | Ems Medical, Inc. | 02/06/1989SE |
| K884911 | Cortronic SCR1000DSF · Traditional | Cortronic Corp. | 01/13/1989SE |
| K884388 | Edentec Model 4700 ScannerDSF · Traditional | Edentec Corp. | 01/10/1989SE |
| K883315 | Edentrace Multi-Charter Model 3700DSF · Traditional | Edentec Corp. | 12/28/1988SE |
| K881831 | WS 800R Thermal Array RecorderDSF · Traditional | Nihon Kohden America, Inc. | 07/14/1988SE |
| K881346 | Lifestat 1600 PrinterDSF · Traditional | Physio-Control Corp. | 06/09/1988SE |
| K880781 | Datalogger Chart RecorderDSF · Traditional | Air-Shields, Inc. | 05/11/1988SE |
| K880554 | Vsm(R) R2 Paper Chart RecorderDSF · Traditional | Physio-Control Corp. | 05/06/1988SE |
| K872822 | Model 78576A Paper Chart RecorderDSF · Traditional | Hewlett-Packard Co. | 11/04/1987SE |
| K870538 | Model 192 PrinterDSF · Traditional | Advanced Medical Products, Inc. | 04/23/1987SE |
| K870119 | Fibre Optic Strip Chart RecorderDSF · Traditional | Apex Imaging Corp. | 04/10/1987SE |
| K870039 | Imagenet Digital Ophthalmic Imaging SystemDSF · Traditional | Par Microsystems Corp. | 02/12/1987SE |
| K863331 | Siredoc 60 and Siredoc 220DSF · Traditional | Siemens Medical Solutions USA, Inc. | 10/06/1986SE |
| K862596 | DR-2C (Modification)DSF · Traditional | General Devices | 09/26/1986SE |
| K855045 | Model 535 Neo-Trak RecorderDSF · Traditional | Ge Medical Systems Information Technologies | 05/16/1986SE |
| K854866 | Long Term Recorder Rag 1200DSF · Traditional | Nihon Kohden America, Inc. | 04/09/1986SE |
| K851625 | SCX-10 Single Channel Recorder Access. for G-2000DSF · Traditional | Eaton Medical Group | 11/19/1985SE |
| K852487 | Fukuda Denshi Model AU-5001-5003 ThermalDSF · Traditional | Fukuda Denshi USA, Inc. | 09/19/1985SE |
| K851626 | SCX-35 Three Channel Access. for Module G-2000 EleDSF · Traditional | Eaton Medical Group | 06/26/1985SE |
| K851274 | Ohmeda Model 0001/0003 RecorderDSF · Traditional | Ohmeda Medical | 05/15/1985SE |
| K850365 | Recording Accessory for G-2000 EKG Mach. GMP-40 ReDSF · Traditional | Eaton Medical Group | 04/09/1985SE |
| K850487 | Novametrix 350 Recorder-Paper Chart RecorderDSF · Traditional | Novametrix Medical Systems, Inc. | 03/29/1985SE |
| K850146 | Siredoc, Paper Chart RecorderDSF · Traditional | Siemens Medical Solutions USA, Inc. | 02/12/1985SE |
| K843836 | Thermal Grayscale RF-100DSF · Traditional | Fukuda Denshi USA, Inc. | 10/19/1984SE |
| K833000 | I-Channel RecorderDSF · Traditional | Litton Medical Electronics | 06/01/1984SE |
| K832998 | 2-CHANNEL RecorderDSF · Traditional | Litton Medical Electronics | 06/01/1984SE |
| K833656 | Narcotrace 40 - NT40DSF · Traditional | Narco Bio-Systems | 05/09/1984SE |
| K832754 | Monitoring System AS100-AS115 RecordDSF · Traditional | Air-Shields, Inc. | 12/22/1983SE |
| K831134 | Phoenix 60/60 Processor ModuleDSF · Traditional | Phoenix Corp. | 11/07/1983SE |
| K832012 | Medical Electronics-Printer ClockDSF · Traditional | Litton Medical Electronics | 10/31/1983SE |
| K830321 | Venture II Monitoring SystemDSF · Traditional | Rae Medical Corp. | 06/03/1983SE |
| K830315 | Dual Channel Recorder #78574ADSF · Traditional | Hewlett-Packard Co. | 03/31/1983SE |
| K822978 | Mingograf 4, Mingo Card 4 & Minocard 3DSF · Traditional | Siemens Corp. | 12/15/1982SE |
| K823210 | Model 525 Neo-Trak Neonatal RecorderDSF · Traditional | Ge Medical Systems Information Technologies | 11/24/1982SE |
| K822983 | Mingocard 7 & Mingophone 7DSF · Traditional | Siemens Corp. | 11/24/1982SE |
| K822432 | Centurion Chart RecorderDSF · Traditional | Clinical Data, Inc. | 11/01/1982SE |
| K821612 | Model 16800 Trend RecorderDSF · Traditional | Healthdyne, Inc. | 07/14/1982SE |
| K821173 | Eventmaster 3 Holter Event ScannerDSF · Traditional | Instruments For Cardiac Research | 05/18/1982SE |
| K820033 | Cardiovue Accessory CartDSF · Traditional | Diasonics, Inc. | 01/22/1982SE |
| K812608 | Vasculab #R12BDSF · Traditional | Medasonics, Inc. | 10/02/1981SE |
| K811540 | Spacelabs' System AutorecorderDSF · Traditional | Spacelabs, Inc. | 08/13/1981SE |
| K811453 | Novatracer RecorderDSF · Traditional | Novametrix Medical Systems, Inc. | 07/10/1981SE |
| K811254 | Paper Chart RecorderDSF · Traditional | American Edwards Laboratories | 07/10/1981SE |
| K810169 | Central Station Controller AC100/CE100DSF · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K810167 | Single Channell Recorder AR110DSF · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K810166 | 1,2,3 Channell Recorders (AR150,AR250,-)DSF · Traditional | Honeywell, Inc. | 02/25/1981SE |
| K803225 | Advancemed ExaminerDSF · Traditional | American Edwards Laboratories | 01/13/1981SE |
| K801830 | Model 9300 ElectrocardiovalidatorDSF · Traditional | Del Mar Avionics | 08/27/1980SE |
| K801549 | Model R11 Single Channel Chart RecorderDSF · Traditional | Medasonics, Inc. | 07/14/1980SE |
| K801485 | Series 602 CKG Recorder (Modified)DSF · Traditional | Cardio Kinetics, Inc. | 07/08/1980SE |
| K800851 | Series 602 Ckgtm RecorderDSF · Traditional | Cardio Kinetics, Inc. | 04/24/1980SE |
| K792105 | Critikon Dual Channel RecorderDSF · Traditional | Critikon Company, LLC | 10/26/1979SE |
| K792099 | 50MM Writer Model CVM 9529DSF · Traditional | C-V Monitors Corp. | 10/26/1979SE |
| K790825 | LS-8 VisicorderDSF · Traditional | Honeywell, Inc. | 05/31/1979SE |
| K781873 | Recorder, Strip Chart with PrinterDSF · Traditional | Midwest Analog & Digital, Inc. | 01/05/1979SE |
| K781867 | Writer, GEMINI-3DSF · Traditional | C-V Monitors Corp. | 01/05/1979SE |
| K781115 | Printer, DigitalDSF · Traditional | Output, Inc. | 10/06/1978SE |
| K780597 | ECG Paper, 3 ChannelDSF · Traditional | Abco Dealers, Inc. | 06/28/1978SE |
| K780677 | 4600 RecorderDSF · Traditional | G & W Applied Science Laboratories | 05/17/1978SE |
| K780640 | Dry Silver Processor Model 1226DSF · Traditional | Honeywell, Inc. | 04/28/1978SE |
| K780245 | Recorder, RE-100P Hot Stylus Strip ChartDSF · Traditional | Waters Assoc., Inc. | 03/27/1978SE |
| K780338 | Minystag MN-1DSF · Traditional | Lkb Instruments, Inc. | 03/15/1978SE |
| K772333 | Recorder, Paper, ECGDSF · Traditional | Telectronics, Inc. | 02/13/1978SE |
| K772054 | Physiological Recorder Model 740DSF · Traditional | Datascope Corp. | 11/22/1977SE |
| K772052 | Physiological Recorder Model 721ADSF · Traditional | Datascope Corp. | 11/22/1977SE |
| K772048 | Single & Dual Channel RecorderDSF · Traditional | Hewlett-Packard Co. | 11/09/1977SE |
| K771372 | System IIDSF · Traditional | Irex Corp. | 08/04/1977SE |
| K770946 | Record, Model 702, I.L.DSF · Traditional | Instrumentation Laboratory CO | 07/05/1977SE |
| K770342 | Recorder, Chart, Model 5536DSF · Traditional | Hudson Oxygen Therapy Sales Co. | 03/01/1977SE |
| K761077 | Trend AnalyzerDSF · Traditional | Eldeco | 12/28/1976SE |
| K761055 | Calculator Plotter (Model 9872A)DSF · Traditional | Hewlett-Packard Co. | 12/09/1976SE |
| K760676 | Lifepak 5 Cardioscope-Recorder ModuleDSF · Traditional | Physio-Control Corp. | 10/13/1976SE |
| K760539 | Recorder (#78640A)DSF · Traditional | Hewlett-Packard Co. | 09/09/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0866-2016 Class II | PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product…The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due… | Gsi Group Inc | 12/02/2015Terminated |