CARDIOLAB AMPLIFIER MODULE (CAM)
FDA 510(k) clearance K910307 · decided 1991-04-12
Clearance details
- K-number
- K910307
- Device name
- CARDIOLAB AMPLIFIER MODULE (CAM)
- Applicant
- Prucka Engineering, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-01-24
- Decision date
- 1991-04-12
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- DRR
- Device class
- 2
- Regulation number
- 870.2050
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Prucka Engineering
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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 |
| HP MODEL 8880A FILTER (K802686) | Hewlett-Packard Co. | 1980-11-26 |
Recalls involving this device
No recalls on record reference this clearance.