Product code DSF
- Device name
- Recorder, Paper Chart
- Medical specialty
- Cardiovascular
- Device class
- 1
- Regulation number
- 870.2810
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K910871 | EDENTEC DIGITAL CHARTER MODEL 3710 | Edentec Corp. | 1991-08-29 |
| K912929 | DASH IV | Astro-Med, Inc. | 1991-08-13 |
| K905856 | MODEL 556 MONITOR | Ge Medical Systems Information Technologies | 1991-01-11 |
| K902586 | GRI LASERGRAPH(TM) ECG PAPER | Gri Medical Products, Inc. | 1990-06-22 |
| K902230 | COLORADO COLOR IMAGING RECORDER | Honeywell, Inc. | 1990-06-19 |
| K901385 | GABRIEL MEDICAL CLS THERMAL RECORDER | Gabriel Medical, Inc. | 1990-05-09 |
| K895111 | TYPE 9541 RECORDER, PAPER CHART | S & W Medico Teknik | 1990-01-26 |
| K894922 | WR3500 AND WR3600 SERIES RECORDERS | Western Graphtec | 1990-01-26 |
| K894736 | MT96000 PAPER CHART RECORDER | Astro-Med, Inc. | 1989-12-13 |
| K894607 | PAQ10 PAPER CHART RECORDER | Protocol Systems, Inc. | 1989-10-26 |
| K893561 | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. | Edentec Corp. | 1989-08-25 |
| K885058 | CARDIOCAP(TM) DR-104 REPORTER | Datex Division Instrumentarium Corp. | 1989-07-14 |
| K890711 | DUAL GRAPH (TM) RECORDER-MONITOR | Somatics, Inc. | 1989-06-02 |
| K884897 | FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER | Mennen Medical, Inc. | 1989-03-09 |
| K890142 | A10 ULTRASCOPE RECORDER | Ems Medical, Inc. | 1989-02-06 |
| K884911 | CORTRONIC SCR1000 | Cortronic Corp. | 1989-01-13 |
| K884388 | EDENTEC MODEL 4700 SCANNER | Edentec Corp. | 1989-01-10 |
| K883315 | EDENTRACE MULTI-CHARTER MODEL 3700 | Edentec Corp. | 1988-12-28 |
| K881831 | WS 800R THERMAL ARRAY RECORDER | Nihon Kohden America, Inc. | 1988-07-14 |
| K881346 | LIFESTAT 1600 PRINTER | Physio-Control Corp. | 1988-06-09 |
| K880781 | DATALOGGER CHART RECORDER | Air-Shields, Inc. | 1988-05-11 |
| K880554 | VSM(R) R2 PAPER CHART RECORDER | Physio-Control Corp. | 1988-05-06 |
| K872822 | MODEL 78576A PAPER CHART RECORDER | Hewlett-Packard Co. | 1987-11-04 |
| K870538 | MODEL 192 PRINTER | Advanced Medical Products, Inc. | 1987-04-23 |
| K870119 | FIBRE OPTIC STRIP CHART RECORDER | Apex Imaging Corp. | 1987-04-10 |
| K870039 | IMAGENET DIGITAL OPHTHALMIC IMAGING SYSTEM | Par Microsystems Corp. | 1987-02-12 |
| K863331 | SIREDOC 60 AND SIREDOC 220 | Siemens Medical Solutions USA, Inc. | 1986-10-06 |
| K862596 | DR-2C (MODIFICATION) | General Devices | 1986-09-26 |
| K855045 | MODEL 535 NEO-TRAK RECORDER | Ge Medical Systems Information Technologies | 1986-05-16 |
| K854866 | LONG TERM RECORDER RAG 1200 | Nihon Kohden America, Inc. | 1986-04-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08428763008774 | PAQ.114X70X250/QT-75HS/WELCH ALLYN CP-5 | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763008767 | PAQ.114X100X150.FETATRACK310 | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763008750 | PAQ.112X100X100BIOCARE | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763008743 | PAQ.112X90X300.CARDICO-601 | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763008736 | PAQ.112X90X160.CADENCE M50-78019 | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763008729 | PAQ.112X100X160.BIOCARE | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763008712 | PAQ.112X150X300.HEARTSCREEN CLINIC | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763007593 | PAQ.112X100X100BIOCARE | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763001812 | ROLLO 58X8X12E/GR60.PRINTER | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763001805 | ROLLO 57X40X12E.PRINTER. | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763001782 | ROLLO 57X15X12E.MATACHANA | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763001775 | ROLLO 57X25X12E. | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763001768 | ROLLO 57X15X12E/GR60/SPIRO501 | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 08428763001751 | ROLLO 57X15X12E/GR60/MICROTR. | AB MEDICA GROUP, S.A. | 2025-11-12 |
| 07640187333213 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187332926 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333190 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333176 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333152 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333145 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333114 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333091 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333077 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333053 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333039 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187333015 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187332995 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187332971 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187332957 | ECG Recording Paper | Diagramma AG | 2023-01-17 |
| 07640187332933 | ECG Recording Paper | Diagramma AG | 2023-01-17 |