The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Modem Accessory For Epi Cardia Sys.
| Device ID | K834034 |
| 510k Number | K834034 |
| Device Name: | MODEM ACCESSORY FOR EPI CARDIA SYS |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MEDICOMP, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-23 |
| Decision Date | 1984-05-09 |