The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Epicardia Anywhere.
| Device ID | K173170 |
| 510k Number | K173170 |
| Device Name: | Epicardia Anywhere |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | Medicomp, Inc. 600 Atlantis Rd Melbourne, FL 32904 |
| Contact | Sean Marcus |
| Correspondent | Susan D. Goldstein-falk mdi Consultants 55 Northern Blvd Great Neck, NY 11021 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-01-10 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EPICARDIA ANYWHERE 87817574 not registered Live/Pending |
Medicomp, Inc. 2018-03-02 |