FDA 510(k), K162891, Complete Control System

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

Total pages: 1732
Fully redacted pages: 1446
Content pages: 286