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FDA 510(k), K153473, Braemar Telemetry Patch System
FDA 510(k), K153473, Braemar Telemetry Patch System
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510(K) Number: K153473
Device Name: Braemar Telemetry Patch System
Manufacturer: Braemar Manufacturing, LLC
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: 870.1025
Classification Product Code: DSI
Date Received: 12/02/2015
Decision Date: 07/22/2016
Regulation Medical Specialty: Cardiovascular
Device Name: Braemar Telemetry Patch System
Manufacturer: Braemar Manufacturing, LLC
Device Classification Name: Detector And Alarm, Arrhythmia
Regulation Number: 870.1025
Classification Product Code: DSI
Date Received: 12/02/2015
Decision Date: 07/22/2016
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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