The following data is part of a premarket notification filed by Braemar, Inc. with the FDA for Braemar Fusion Wireless - Ambulatory Ecg Arrhythmia Monitoring System.
| Device ID | K081444 |
| 510k Number | K081444 |
| Device Name: | BRAEMAR FUSION WIRELESS - AMBULATORY ECG ARRHYTHMIA MONITORING SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| 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 | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-22 |
| Decision Date | 2008-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B146FUSTLC0 | K081444 | 000 |
| B146FUSLS0 | K081444 | 000 |
| B146FUSFCM0 | K081444 | 000 |
| B146FUSB0 | K081444 | 000 |