Panels › Cardiovascular › Product code DRR · Class 2
Amplifier And Signal Conditioner, Biopotential
Regulation 870.2050
0510(k)s in 12 months (24 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in DRR
| Company | 510(k)s | Recalls |
|---|---|---|
| Hewlett-Packard Co. | 5 | 0 |
| Astro-Med, Inc. | 2 | 0 |
| Quinton Electrophysiology Corp. | 2 | 0 |
| Arzbaecher & Co. | 1 | 0 |
| Biocheck, Inc. | 1 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| C-V Monitors Corp. | 1 | 0 |
| Cardiac Pacemakers, Inc. | 1 | 0 |
| Codman & Shurtleff, Inc. | 1 | 0 |
| Consolidated Medical Equipment, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 19, 2002 | K022660 | BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 Biocheck, Inc. | DRR |
| Dec 29, 1997 | K971570 | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 Quinton Electrophysiology Corp. | DRR |
| Apr 30, 1993 | K925346 | EP AMP, MODEL #901 Quinton Electrophysiology Corp., CA | DRR |
| Jan 28, 1992 | K914381 | HORIZON 9000/HIS OPTION AMPLIFIER Mennen Medical, Inc. | DRR |
| Jul 22, 1991 | K911935 | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED Gould, Inc. | DRR |
| Apr 12, 1991 | K910307 | CARDIOLAB AMPLIFIER MODULE (CAM) Prucka Engineering, Inc. | DRR |
| Sep 18, 1989 | K894735 | ASC-952 PHYSIOLOGICAL AMPLIFIER Astro-Med, Inc. | DRR |
| Aug 3, 1989 | K894161 | ASC-950 ECG AMPLIFIER Astro-Med, Inc. | DRR |
| Jan 19, 1988 | K874441 | BARD BIOPOTENTIAL AMPLIFIER C.R. Bard, Inc. | DRR |
| Jan 16, 1986 | K853652 | BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT Fisher Imaging Corp. | DRR |
| Nov 27, 1981 | K813123 | EPC FILTER Codman & Shurtleff, Inc. | DRR |
| Apr 10, 1981 | K810828 | NON-INVASIVE AMPLIFIER Henry Ford Hospital | DRR |
| Nov 26, 1980 | K802686 | HP MODEL 8880A FILTER Hewlett-Packard Co. | DRR |
| Oct 10, 1980 | K802282 | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON Consolidated Medical Equipment, Inc. | DRR |
| Nov 21, 1979 | K792283 | ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON Arzbaecher & Co. | DRR |
| Oct 11, 1979 | K791964 | MODEL 15055A MAINFRAME Hewlett-Packard Co. | DRR |
| Mar 2, 1979 | K790203 | INTERVAL TIMER MODEL V4295 Electronics For Medicine, Inc. | DRR |
| May 9, 1978 | K780572 | DCG PREAMPLIFIER MODULE C-V Monitors Corp. | DRR |
| Feb 13, 1978 | K780043 | ESIS MODULE Datascope Corp. | DRR |
| Nov 22, 1977 | K772132 | AMPLIFIER MODULE, 78211A ECG Hewlett-Packard Co. | DRR |
| Nov 9, 1977 | K771976 | ECG AMPLIFIER/R WAVE TRIGGER G.D. Searle and Co. | DRR |
| Aug 30, 1977 | K771572 | PATIENT MONITORS MODELS 78701A/78702A Hewlett-Packard Co. | DRR |
| Feb 14, 1977 | K770243 | ELGILOY STYLET Cardiac Pacemakers, Inc. | DRR |
| Dec 9, 1976 | K761056 | DISPLAY MONITOR (MODEL 78301A) Hewlett-Packard Co. | DRR |
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