The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Telepatch Cardiac Monitor.
| Device ID | K161916 |
| 510k Number | K161916 |
| Device Name: | TelePatch Cardiac Monitor |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | MEDICOMP, INC. 600 ATLANTIS RD Melbourne, FL 32904 |
| Contact | Sean Marcus |
| Correspondent | Susan D. Goldstein-falk MDI CONSULTANTS 55 NORTHERN BLVD Suite 200 Great Neck, NY 11021 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-12 |
| Decision Date | 2016-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862887000388 | K161916 | 000 |
| 00862887000319 | K161916 | 000 |