The following data is part of a premarket notification filed by Braemar Corp. with the FDA for Digitrakplus Holter Recorder.
| Device ID | K993617 |
| 510k Number | K993617 |
| Device Name: | DIGITRAKPLUS HOLTER RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | BRAEMAR CORP. 11481 RUPP DR. Burnsville, MN 55337 |
| Contact | David Norberg |
| Correspondent | David Norberg BRAEMAR CORP. 11481 RUPP DR. Burnsville, MN 55337 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-26 |
| Decision Date | 1999-11-24 |
| Summary: | summary |