CARIEL F12
FDA 510(k) clearance K823934 · decided 1983-12-16
Clearance details
- K-number
- K823934
- Device name
- CARIEL F12
- Applicant
- Odam
- Decision
- Substantially Equivalent
- Date received
- 1982-12-29
- Decision date
- 1983-12-16
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- DYC
- Device class
- 2
- Regulation number
- 870.2400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- France, FR
- 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 |
|---|---|---|
| MIDA ALGORITHM REV. B (K023414) | Ortivus AB | 2003-12-05 |
| MIDA SYSTEM, MODELS 1000/1100 (K896396) | Medical Graphics Corp. | 1990-01-18 |
| DIRECT WRITING VECTORCARDIOGRAPH (K810529) | Elmed, Inc. | 1981-04-23 |
Recalls involving this device
No recalls on record reference this clearance.