The following data is part of a premarket notification filed by Braemar, Inc. with the FDA for Braemar Er800 Series Enhanced Algorithm Event Recorder.
| Device ID | K042469 |
| 510k Number | K042469 |
| Device Name: | BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | BRAEMAR, INC. 11481 RUPP DR. Burnsville, MN 55337 |
| Contact | Darren Dershem |
| Correspondent | Darren Dershem BRAEMAR, INC. 11481 RUPP DR. Burnsville, MN 55337 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-13 |
| Decision Date | 2004-10-06 |