Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Electrode, Cutaneous
510(k) Number K191083
Device Name COMPLETE CONTROL System Gen2
Applicant
Coapt, LLC
222 W. Ontario St., Suite #300
Chicago,  IL  60654
Applicant Contact Blair A Lock
Correspondent
Coapt, LLC
222 W. Ontario St., 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
Predetermined Change
Control Plan Authorized		 No
-
-