The following data is part of a premarket notification filed by Odam with the FDA for Cariel F12.
| Device ID | K823934 |
| 510k Number | K823934 |
| Device Name: | CARIEL F12 |
| Classification | Vectorcardiograph |
| Applicant | ODAM SIEGE SOCIAL 67160 WISSEMBOURG FRANCE , FR |
| Contact | REITHLER |
| Correspondent | REITHLER ODAM SIEGE SOCIAL 67160 WISSEMBOURG FRANCE , FR |
| Product Code | DYC |
| CFR Regulation Number | 870.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-29 |
| Decision Date | 1983-12-16 |