The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Epicardia 5000.
| Device ID | K090834 |
| 510k Number | K090834 |
| Device Name: | EPICARDIA 5000 |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | MEDICOMP, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk MEDICOMP, INC. 55 Northern Blvd. Suite 200 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 | 2009-03-27 |
| Decision Date | 2009-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862887000302 | K090834 | 000 |