Amplifier And Signal Conditioner, Biopotential
FDA product code DRR · Class II (moderate risk) · 21 CFR 870.2050 · Cardiovascular
24510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Hewlett-Packard Co. 5
- Quinton Electrophysiology Corp. 2
- Astro-Med, Inc. 2
- Codman & Shurtleff, Inc. 1
- BioCheck Inc 1
- Mennen Medical, Inc. 1
- Gould, Inc. 1
- Prucka Engineering, Inc. 1
- C.R. Bard, Inc. 1
- Fisher Imaging Corp. 1
- Henry Ford Hospital 1
- Consolidated Medical Equipment, Inc. 1
- Arzbaecher & Co. 1
- Electronics For Medicine, Inc. 1
- C-V Monitors Corp. 1
- Datascope Corp. 1
- G.D. Searle and Co. 1
- Cardiac Pacemakers, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K022660 | Biocheck Myoglobin Elisa, Model BC-1117DRR · Traditional | Biocheck, Inc. | 12/19/2002SE |
| K971570 | Epxpress System (Timberwolf Revision) /000391DRR · Traditional | Quinton Electrophysiology Corp. | 12/29/1997SE |
| K925346 | Ep Amp, Model #901DRR · Traditional | Quinton Electrophysiology Corp. | 04/30/1993SE |
| K914381 | Horizon 9000/HIS Option AmplifierDRR · Traditional | Mennen Medical, Inc. | 01/28/1992SE |
| K911935 | Cardiac Electrophysical Lead Selector, ModifiedDRR · Traditional | Gould, Inc. | 07/22/1991SE |
| K910307 | Cardiolab Amplifier Module (Cam)DRR · Traditional | Prucka Engineering, Inc. | 04/12/1991SE |
| K894735 | ASC-952 Physiological AmplifierDRR · Traditional | Astro-Med, Inc. | 09/18/1989SE |
| K894161 | ASC-950 ECG AmplifierDRR · Traditional | Astro-Med, Inc. | 08/03/1989SE |
| K874441 | Bard Biopotential AmplifierDRR · Traditional | C.R. Bard, Inc. | 01/19/1988SE |
| K853652 | BERS-400A Electrophysiological Amplifiers & InputDRR · Traditional | Fisher Imaging Corp. | 01/16/1986SE |
| K813123 | Epc FilterDRR · Traditional | Codman & Shurtleff, Inc. | 11/27/1981SE |
| K810828 | Non-Invasive AmplifierDRR · Traditional | Henry Ford Hospital | 04/10/1981SE |
| K802686 | HP Model 8880A FilterDRR · Traditional | Hewlett-Packard Co. | 11/26/1980SE |
| K802282 | Esophageal ECG Preamplifier & Signal ConDRR · Traditional | Consolidated Medical Equipment, Inc. | 10/10/1980SE |
| K792283 | Esophageal ECG Preamplifier & Signal ConDRR · Traditional | Arzbaecher & Co. | 11/21/1979SE |
| K791964 | Model 15055A MainframeDRR · Traditional | Hewlett-Packard Co. | 10/11/1979SE |
| K790203 | Interval Timer Model V4295DRR · Traditional | Electronics For Medicine, Inc. | 03/02/1979SE |
| K780572 | DCG Preamplifier ModuleDRR · Traditional | C-V Monitors Corp. | 05/09/1978SE |
| K780043 | Esis ModuleDRR · Traditional | Datascope Corp. | 02/13/1978SE |
| K772132 | Amplifier Module, 78211A ECGDRR · Traditional | Hewlett-Packard Co. | 11/22/1977SE |
| K771976 | ECG Amplifier/R Wave TriggerDRR · Traditional | G.D. Searle and Co. | 11/09/1977SE |
| K771572 | Patient Monitors Models 78701A/78702ADRR · Traditional | Hewlett-Packard Co. | 08/30/1977SE |
| K770243 | Elgiloy StyletDRR · Traditional | Cardiac Pacemakers, Inc. | 02/14/1977SE |
| K761056 | Display Monitor (Model 78301A)DRR · Traditional | Hewlett-Packard Co. | 12/09/1976SE |