The following data is part of a premarket notification filed by Braemar, Inc. with the FDA for Modification To: Braemar Er900 Series Enhanced Algorithm Ecg Event Recorder.
| Device ID | K071011 |
| 510k Number | K071011 |
| Device Name: | MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| 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 | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-10 |
| Decision Date | 2007-04-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B146PERP0 | K071011 | 000 |
| B146PERB0 | K071011 | 000 |
| B146ER9RAF0 | K071011 | 000 |
| B146ER9R0 | K071011 | 000 |
| B146ER9BAF0 | K071011 | 000 |
| B146ER9B0 | K071011 | 000 |