The following data is part of a premarket notification filed by Braemar Manufacturing, Llc with the FDA for Braemar Telemetry Patch System.
| Device ID | K153473 |
| 510k Number | K153473 |
| Device Name: | Braemar Telemetry Patch System |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | Braemar Manufacturing, LLC 3890 Murphy Canyon Road, Suite 100 San Diego, CA 92123 |
| Contact | Kent Sayler |
| Correspondent | Kent Sayler Braemar Manufacturing, LLC 3890 Murphy Canyon Road, Suite 100 San Diego, CA 92123 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-02 |
| Decision Date | 2016-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B146M10 | K153473 | 000 |
| B146C6M20 | K153473 | 000 |
| B146BTPM0 | K153473 | 000 |
| B146C6D0 | K153473 | 000 |
| B146C6D10 | K153473 | 000 |
| B146C6E10 | K153473 | 000 |
| B146C6M40 | K153473 | 000 |
| B146C6M50 | K153473 | 000 |
| B146C6M60 | K153473 | 000 |
| B146C6M70 | K153473 | 000 |
| B146C6M80 | K153473 | 000 |
| B146C6M90 | K153473 | 000 |
| B146C6R10 | K153473 | 000 |
| B146C6R20 | K153473 | 000 |
| B146C6S0 | K153473 | 000 |
| B146C6R30 | K153473 | 000 |