K823934 is an FDA 510(k) clearance for the CARIEL F12. This device is classified as a Vectorcardiograph (Class II - Special Controls, product code DYC).
Submitted by Odam (France, FR). The FDA issued a Cleared decision on December 16, 1983, 352 days after receiving the submission on December 29, 1982.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2400.
| 510(k) Number | K823934 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1982 |
| Decision Date | December 16, 1983 |
| Days to Decision | 352 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DYC — Vectorcardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2400 |