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 |