510(k) K153473
K153473 is an FDA 510(k) premarket notification submitted by Braemar Manufacturing, LLC for the device "Braemar Telemetry Patch System". The FDA issued a decision of Substantially Equivalent on July 22, 2016. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Braemar Manufacturing, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2016
- Date Received
- December 2, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector And Alarm, Arrhythmia
- Device Class
- Class II
- Regulation Number
- 870.1025
- Review Panel
- CV
- Submission Type