The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Epicardia.
| Device ID | K952846 |
| 510k Number | K952846 |
| Device Name: | EPICARDIA |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | MEDICOMP, INC. 7845 ELLIS RD. West Melbourne, FL 32904 |
| Contact | Bob Bruce |
| Correspondent | Bob Bruce MEDICOMP, INC. 7845 ELLIS RD. West Melbourne, FL 32904 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-21 |
| Decision Date | 1995-09-18 |