The following data is part of a premarket notification filed by Braemar Corp. with the FDA for Braemar Model Dl700 Ambulatory Electrocardiographic Recorder.
| Device ID | K945130 |
| 510k Number | K945130 |
| Device Name: | BRAEMAR MODEL DL700 AMBULATORY ELECTROCARDIOGRAPHIC RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | BRAEMAR CORP. 11481 RUPP DR. Burnsville, MN 55337 |
| Contact | Dave Norberg |
| Correspondent | Dave Norberg BRAEMAR CORP. 11481 RUPP DR. Burnsville, MN 55337 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-19 |
| Decision Date | 1995-04-12 |