The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Epicardia Pc/fc.
| Device ID | K883103 |
| 510k Number | K883103 |
| Device Name: | EPICARDIA PC/FC |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDICOMP, INC. 7845 ELLIS RD. West Melbourne, FL 32904 |
| Contact | Riffe |
| Correspondent | Riffe MEDICOMP, INC. 7845 ELLIS RD. West Melbourne, FL 32904 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-22 |
| Decision Date | 1988-09-22 |