The following data is part of a premarket notification filed by Braemar, Inc. with the FDA for Dl900 Series Holter Recorder.
| Device ID | K071733 |
| 510k Number | K071733 |
| Device Name: | DL900 SERIES HOLTER 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 | 2007-06-26 |
| Decision Date | 2007-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838032965 | K071733 | 000 |
| B146DL9B70 | K071733 | 000 |
| B146DL9B0 | K071733 | 000 |
| B146DL9AT0 | K071733 | 000 |
| B146DL95000 | K071733 | 000 |
| B146DL95030 | K071733 | 000 |
| B146DL95020 | K071733 | 000 |
| B146DL95010 | K071733 | 000 |
| B146DL9ZW0 | K071733 | 000 |
| B146DL9BD0 | K071733 | 000 |
| B146DL9BK0 | K071733 | 000 |
| B146DL9BS0 | K071733 | 000 |
| 00884838032958 | K071733 | 000 |
| 00884838032941 | K071733 | 000 |
| 00884838000476 | K071733 | 000 |
| B146DL9ST0 | K071733 | 000 |
| B146DL9RA0 | K071733 | 000 |
| B146DL9NV0 | K071733 | 000 |
| B146DL9NE0 | K071733 | 000 |
| B146DL9FM0 | K071733 | 000 |
| B146DL9280 | K071733 | 000 |