CENTURION CARDIAC DETECTOR
FDA 510(k) clearance K832828 · decided 1984-05-09
Clearance details
- K-number
- K832828
- Device name
- CENTURION CARDIAC DETECTOR
- Applicant
- Clinical Data Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-19
- Decision date
- 1984-05-09
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- DRJ
- Device class
- 1
- Regulation number
- 870.2600
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Walker, MI, 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 |
|---|---|---|
| PRESSURE ISOLATION AMPLIFIER #9813 517 (K822590) | Honeywell, Inc. | 1982-10-04 |
| AMPLIFIER MODEL N5A-HIS (K771685) | Honeywell, Inc. | 1977-09-14 |
| AMPLIFIER MODEL N5A-ECG (K771684) | Honeywell, Inc. | 1977-09-14 |
Recalls involving this device
No recalls on record reference this clearance.