The following data is part of a premarket notification filed by Braemar Manufacturing Llc with the FDA for Braemar Cardiokey Holter Recorder.
| Device ID | K130294 |
| 510k Number | K130294 |
| Device Name: | BRAEMAR CARDIOKEY HOLTER RECORDER |
| Classification | Electrocardiograph, Ambulatory (without Analysis) |
| Applicant | BRAEMAR MANUFACTURING LLC 750 B. STREET, STUITE 1400 San Diego, CA 92101 |
| Contact | Kent Sayler |
| Correspondent | Kent Sayler BRAEMAR MANUFACTURING LLC 750 B. STREET, STUITE 1400 San Diego, CA 92101 |
| Product Code | MWJ |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-06 |
| Decision Date | 2013-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B146CK0 | K130294 | 000 |