DSF · Recorder, Paper Chart
Cardiovascular · 21 CFR 870.2810 · Class 1
Overview
| Product Code | DSF |
|---|---|
| Device Name | Recorder, Paper Chart |
| Regulation | 21 CFR 870.2810 |
| Device Class | Class 1 |
| Review Panel | Cardiovascular |
Identification
A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (20 of 87)
Showing 20 most recent of 87 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K910871 | EDENTEC DIGITAL CHARTER MODEL 3710 | Edentec Corp. | Aug 29, 1991 | SESE |
| K912929 | DASH IV | Astro-Med, Inc. | Aug 13, 1991 | SESE |
| K905856 | MODEL 556 MONITOR | Ge Medical Systems Information Technologies | Jan 11, 1991 | SESE |
| K902586 | GRI LASERGRAPH(TM) ECG PAPER | Gri Medical Products, Inc. | Jun 22, 1990 | SESE |
| K902230 | COLORADO COLOR IMAGING RECORDER | Honeywell, Inc. | Jun 19, 1990 | SESE |
| K901385 | GABRIEL MEDICAL CLS THERMAL RECORDER | Gabriel Medical, Inc. | May 9, 1990 | SESE |
| K895111 | TYPE 9541 RECORDER, PAPER CHART | S & W Medico Teknik | Jan 26, 1990 | SESE |
| K894922 | WR3500 AND WR3600 SERIES RECORDERS | Western Graphtec | Jan 26, 1990 | SESE |
| K894736 | MT96000 PAPER CHART RECORDER | Astro-Med, Inc. | Dec 13, 1989 | SESE |
| K894607 | PAQ10 PAPER CHART RECORDER | Protocol Systems, Inc. | Oct 26, 1989 | SESE |
| K893561 | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. | Edentec Corp. | Aug 25, 1989 | SESE |
| K885058 | CARDIOCAP(TM) DR-104 REPORTER | Datex Division Instrumentarium Corp. | Jul 14, 1989 | SESE |
| K890711 | DUAL GRAPH (TM) RECORDER-MONITOR | Somatics, Inc. | Jun 2, 1989 | SESE |
| K884897 | FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER | Mennen Medical, Inc. | Mar 9, 1989 | SESE |
| K890142 | A10 ULTRASCOPE RECORDER | Ems Medical, Inc. | Feb 6, 1989 | SESE |
| K884911 | CORTRONIC SCR1000 | Cortronic Corp. | Jan 13, 1989 | SESE |
| K884388 | EDENTEC MODEL 4700 SCANNER | Edentec Corp. | Jan 10, 1989 | SESE |
| K883315 | EDENTRACE MULTI-CHARTER MODEL 3700 | Edentec Corp. | Dec 28, 1988 | SESE |
| K881831 | WS 800R THERMAL ARRAY RECORDER | Nihon Kohden America, Inc. | Jul 14, 1988 | SESE |
| K881346 | LIFESTAT 1600 PRINTER | Physio-Control Corp. | Jun 9, 1988 | SESE |
Top Applicants
- Honeywell, Inc. — 6 clearances
- Hewlett-Packard Co. — 5 clearances
- Edentec Corp. — 4 clearances
- Eaton Medical Group — 3 clearances
- Ge Medical Systems Information Technologies — 3 clearances
