Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2050](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2050) → DRR — Amplifier And Signal Conditioner, Biopotential # DRR · Amplifier And Signal Conditioner, Biopotential _Cardiovascular · 21 CFR 870.2050 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR ## Overview - **Product Code:** DRR - **Device Name:** Amplifier And Signal Conditioner, Biopotential - **Regulation:** [21 CFR 870.2050](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2050) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **3rd-party reviewable:** yes ## Identification A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 24) Showing 20 most recent of 24 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K022660](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K022660.md) | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | Biocheck, Inc. | Dec 19, 2002 | SESE | | [K971570](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K971570.md) | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 | Quinton Electrophysiology Corp. | Dec 29, 1997 | SESE | | [K925346](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K925346.md) | EP AMP, MODEL #901 | Quinton Electrophysiology Corp. | Apr 30, 1993 | SESE | | [K914381](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K914381.md) | HORIZON 9000/HIS OPTION AMPLIFIER | Mennen Medical, Inc. | Jan 28, 1992 | SESE | | [K911935](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K911935.md) | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED | Gould, Inc. | Jul 22, 1991 | SESE | | [K910307](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K910307.md) | CARDIOLAB AMPLIFIER MODULE (CAM) | Prucka Engineering, Inc. | Apr 12, 1991 | SESE | | [K894735](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K894735.md) | ASC-952 PHYSIOLOGICAL AMPLIFIER | Astro-Med, Inc. | Sep 18, 1989 | SESE | | [K894161](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K894161.md) | ASC-950 ECG AMPLIFIER | Astro-Med, Inc. | Aug 3, 1989 | SESE | | [K874441](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K874441.md) | BARD BIOPOTENTIAL AMPLIFIER | C.R. Bard, Inc. | Jan 19, 1988 | SESE | | [K853652](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K853652.md) | BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT | Fisher Imaging Corp. | Jan 16, 1986 | SESE | | [K813123](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K813123.md) | EPC FILTER | Codman & Shurtleff, Inc. | Nov 27, 1981 | SESE | | [K810828](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K810828.md) | NON-INVASIVE AMPLIFIER | Henry Ford Hospital | Apr 10, 1981 | SESE | | [K802686](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K802686.md) | HP MODEL 8880A FILTER | Hewlett-Packard Co. | Nov 26, 1980 | SESE | | [K802282](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K802282.md) | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | Consolidated Medical Equipment, Inc. | Oct 10, 1980 | SESE | | [K792283](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K792283.md) | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | Arzbaecher & Co. | Nov 21, 1979 | SESE | | [K791964](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K791964.md) | MODEL 15055A MAINFRAME | Hewlett-Packard Co. | Oct 11, 1979 | SESE | | [K790203](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K790203.md) | INTERVAL TIMER MODEL V4295 | Electronics For Medicine, Inc. | Mar 2, 1979 | SESE | | [K780572](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K780572.md) | DCG PREAMPLIFIER MODULE | C-V Monitors Corp. | May 9, 1978 | SESE | | [K780043](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K780043.md) | ESIS MODULE | Datascope Corp. | Feb 13, 1978 | SESE | | [K772132](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR/K772132.md) | AMPLIFIER MODULE, 78211A ECG | Hewlett-Packard Co. | Nov 22, 1977 | SESE | ## Top Applicants - Hewlett-Packard Co. — 5 clearances - Astro-Med, Inc. — 2 clearances - Quinton Electrophysiology Corp. — 2 clearances - Arzbaecher & Co. — 1 clearance - Biocheck, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/DRR) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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