Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2810](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2810) → DSF — Recorder, Paper Chart # DSF · Recorder, Paper Chart _Cardiovascular · 21 CFR 870.2810 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF ## Overview - **Product Code:** DSF - **Device Name:** Recorder, Paper Chart - **Regulation:** [21 CFR 870.2810](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2810) - **Device Class:** 1 - **Review Panel:** [Cardiovascular](/submissions/CV) ## 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](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K910871.md) | EDENTEC DIGITAL CHARTER MODEL 3710 | Edentec Corp. | Aug 29, 1991 | SESE | | [K912929](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K912929.md) | DASH IV | Astro-Med, Inc. | Aug 13, 1991 | SESE | | [K905856](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K905856.md) | MODEL 556 MONITOR | Ge Medical Systems Information Technologies | Jan 11, 1991 | SESE | | [K902586](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K902586.md) | GRI LASERGRAPH(TM) ECG PAPER | Gri Medical Products, Inc. | Jun 22, 1990 | SESE | | [K902230](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K902230.md) | COLORADO COLOR IMAGING RECORDER | Honeywell, Inc. | Jun 19, 1990 | SESE | | [K901385](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K901385.md) | GABRIEL MEDICAL CLS THERMAL RECORDER | Gabriel Medical, Inc. | May 9, 1990 | SESE | | [K895111](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K895111.md) | TYPE 9541 RECORDER, PAPER CHART | S & W Medico Teknik | Jan 26, 1990 | SESE | | [K894922](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K894922.md) | WR3500 AND WR3600 SERIES RECORDERS | Western Graphtec | Jan 26, 1990 | SESE | | [K894736](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K894736.md) | MT96000 PAPER CHART RECORDER | Astro-Med, Inc. | Dec 13, 1989 | SESE | | [K894607](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K894607.md) | PAQ10 PAPER CHART RECORDER | Protocol Systems, Inc. | Oct 26, 1989 | SESE | | [K893561](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K893561.md) | EDENTRACE 670 SYSTEM MULTICHANNEL RECORDER W/OXIM. | Edentec Corp. | Aug 25, 1989 | SESE | | [K885058](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K885058.md) | CARDIOCAP(TM) DR-104 REPORTER | Datex Division Instrumentarium Corp. | Jul 14, 1989 | SESE | | [K890711](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K890711.md) | DUAL GRAPH (TM) RECORDER-MONITOR | Somatics, Inc. | Jun 2, 1989 | SESE | | [K884897](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K884897.md) | FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER | Mennen Medical, Inc. | Mar 9, 1989 | SESE | | [K890142](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K890142.md) | A10 ULTRASCOPE RECORDER | Ems Medical, Inc. | Feb 6, 1989 | SESE | | [K884911](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K884911.md) | CORTRONIC SCR1000 | Cortronic Corp. | Jan 13, 1989 | SESE | | [K884388](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K884388.md) | EDENTEC MODEL 4700 SCANNER | Edentec Corp. | Jan 10, 1989 | SESE | | [K883315](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K883315.md) | EDENTRACE MULTI-CHARTER MODEL 3700 | Edentec Corp. | Dec 28, 1988 | SESE | | [K881831](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K881831.md) | WS 800R THERMAL ARRAY RECORDER | Nihon Kohden America, Inc. | Jul 14, 1988 | SESE | | [K881346](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF/K881346.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DSF) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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