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FDA 510(k), K171410, ePatch
FDA 510(k), K171410, ePatch
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510(K) Number: K171410
Device Name: ePatch
Manufacturer: Braemar Manufacturing, LLC
Device Classification Name: recorder, magnetic tape, medical
Regulation Number: 870.2800
Classification Product Code: DSH
Date Received: 05/15/2017
Decision Date: 01/04/2018
Regulation Medical Specialty: Cardiovascular
Device Name: ePatch
Manufacturer: Braemar Manufacturing, LLC
Device Classification Name: recorder, magnetic tape, medical
Regulation Number: 870.2800
Classification Product Code: DSH
Date Received: 05/15/2017
Decision Date: 01/04/2018
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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