FDA 510(k), K162891, Complete Control System
FDA 510(k), K162891, Complete Control System
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510(K) Number: K162891
Device Name: Complete Control System
Manufacturer: COAPT, LLC
Device Classification Name: electrode, cutaneous
Regulation Number: 882.1320
Classification Product Code: GXY
Date Received: 10/17/2016
Decision Date: 04/14/2017
Regulation Medical Specialty: Neurology
Device Name: Complete Control System
Manufacturer: COAPT, LLC
Device Classification Name: electrode, cutaneous
Regulation Number: 882.1320
Classification Product Code: GXY
Date Received: 10/17/2016
Decision Date: 04/14/2017
Regulation Medical Specialty: Neurology
- 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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