DRR · Amplifier And Signal Conditioner, Biopotential
Cardiovascular · 21 CFR 870.2050 · Class 2
Overview
| Product Code | DRR |
|---|---|
| Device Name | Amplifier And Signal Conditioner, Biopotential |
| Regulation | 21 CFR 870.2050 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 | Biocheck, Inc. | Dec 19, 2002 | SESE |
| K971570 | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 | Quinton Electrophysiology Corp. | Dec 29, 1997 | SESE |
| K925346 | EP AMP, MODEL #901 | Quinton Electrophysiology Corp. | Apr 30, 1993 | SESE |
| K914381 | HORIZON 9000/HIS OPTION AMPLIFIER | Mennen Medical, Inc. | Jan 28, 1992 | SESE |
| K911935 | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED | Gould, Inc. | Jul 22, 1991 | SESE |
| K910307 | CARDIOLAB AMPLIFIER MODULE (CAM) | Prucka Engineering, Inc. | Apr 12, 1991 | SESE |
| K894735 | ASC-952 PHYSIOLOGICAL AMPLIFIER | Astro-Med, Inc. | Sep 18, 1989 | SESE |
| K894161 | ASC-950 ECG AMPLIFIER | Astro-Med, Inc. | Aug 3, 1989 | SESE |
| K874441 | BARD BIOPOTENTIAL AMPLIFIER | C.R. Bard, Inc. | Jan 19, 1988 | SESE |
| K853652 | BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT | Fisher Imaging Corp. | Jan 16, 1986 | SESE |
| K813123 | EPC FILTER | Codman & Shurtleff, Inc. | Nov 27, 1981 | SESE |
| K810828 | NON-INVASIVE AMPLIFIER | Henry Ford Hospital | Apr 10, 1981 | SESE |
| K802686 | HP MODEL 8880A FILTER | Hewlett-Packard Co. | Nov 26, 1980 | SESE |
| K802282 | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | Consolidated Medical Equipment, Inc. | Oct 10, 1980 | SESE |
| K792283 | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON | Arzbaecher & Co. | Nov 21, 1979 | SESE |
| K791964 | MODEL 15055A MAINFRAME | Hewlett-Packard Co. | Oct 11, 1979 | SESE |
| K790203 | INTERVAL TIMER MODEL V4295 | Electronics For Medicine, Inc. | Mar 2, 1979 | SESE |
| K780572 | DCG PREAMPLIFIER MODULE | C-V Monitors Corp. | May 9, 1978 | SESE |
| K780043 | ESIS MODULE | Datascope Corp. | Feb 13, 1978 | SESE |
| K772132 | 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
