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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K191083
Device Name COMPLETE CONTROL System Gen2
Applicant
Coapt, LLC
222 W. Ontario Street, Suite #300
Chicago,  IL  60654
Applicant Contact Blair A Lock
Correspondent
Coapt, LLC
222 W. Ontario Street, Suite #300
Chicago,  IL  60654
Correspondent Contact Blair A Lock
Regulation Number882.1320
Classification Product Code
GXY  
Subsequent Product Code
IQZ  
Date Received04/24/2019
Decision Date 05/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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