The following data is part of a premarket notification filed by Braemar, Inc. with the FDA for Braemar Er900 Wireless Series Arrhythmia Event Recorder.
| Device ID | K072008 |
| 510k Number | K072008 |
| Device Name: | BRAEMAR ER900 WIRELESS SERIES ARRHYTHMIA EVENT RECORDER |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | BRAEMAR, INC. 1285 CORPORATE CENTER DR. SUITE 150 Eagan, MN 55121 |
| Contact | Darren Dershem |
| Correspondent | Darren Dershem BRAEMAR, INC. 1285 CORPORATE CENTER DR. SUITE 150 Eagan, MN 55121 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-23 |
| Decision Date | 2007-10-03 |