The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Epicardia, Pc.
| Device ID | K843513 |
| 510k Number | K843513 |
| Device Name: | EPICARDIA, PC |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDICOMP, INC. 1250 WEST NASA BLVD. Milbourne , FL 32901 - |
| Contact | Charles C Busby |
| Correspondent | Charles C Busby MEDICOMP, INC. 1250 WEST NASA BLVD. Milbourne , FL 32901 - |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-10-22 |