The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Cardiopal Model Number Pm20.
| Device ID | K981119 |
| 510k Number | K981119 |
| Device Name: | CARDIOPAL MODEL NUMBER PM20 |
| Classification | Transmitters And Receivers, Electrocardiograph, Telephone |
| Applicant | MEDICOMP, INC. 7845 ELLIS RD. West Melbourne, FL 32904 |
| Contact | Josephus Riffe |
| Correspondent | Josephus Riffe MEDICOMP, INC. 7845 ELLIS RD. West Melbourne, FL 32904 |
| Product Code | DXH |
| CFR Regulation Number | 870.2920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-27 |
| Decision Date | 1998-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862887000364 | K981119 | 000 |