AMPLIFIER MODULE, 78211A ECG
FDA 510(k) clearance K772132 · decided 1977-11-22
Clearance details
- K-number
- K772132
- Device name
- AMPLIFIER MODULE, 78211A ECG
- Applicant
- Hewlett-Packard Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-11-14
- Decision date
- 1977-11-22
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- DRR
- Device class
- 2
- Regulation number
- 870.2050
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (K022660) | Biocheck, Inc. | 2002-12-19 |
| EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 (K971570) | Quinton Electrophysiology Corp. | 1997-12-29 |
| EP AMP, MODEL #901 (K925346) | Quinton Electrophysiology Corp. | 1993-04-30 |
| HORIZON 9000/HIS OPTION AMPLIFIER (K914381) | Mennen Medical, Inc. | 1992-01-28 |
| CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (K911935) | Gould, Inc. | 1991-07-22 |
| CARDIOLAB AMPLIFIER MODULE (CAM) (K910307) | Prucka Engineering, Inc. | 1991-04-12 |
| ASC-952 PHYSIOLOGICAL AMPLIFIER (K894735) | Astro-Med, Inc. | 1989-09-18 |
| ASC-950 ECG AMPLIFIER (K894161) | Astro-Med, Inc. | 1989-08-03 |
| BARD BIOPOTENTIAL AMPLIFIER (K874441) | C.R. Bard, Inc. | 1988-01-19 |
| BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT (K853652) | Fisher Imaging Corp. | 1986-01-16 |
| EPC FILTER (K813123) | Codman & Shurtleff, Inc. | 1981-11-27 |
| NON-INVASIVE AMPLIFIER (K810828) | Henry Ford Hospital | 1981-04-10 |
Recalls involving this device
No recalls on record reference this clearance.