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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K160350
Device Name ECG CT Gating Device
Applicant
Neocoil, LLC
N27 W23910a Paul Rd.
Pewaukee,  WI  53072
Applicant Contact MICHAEL LEIGH
Correspondent
Neocoil, LLC
N27 W23910a Paul Rd.
Pewaukee,  WI  53072
Correspondent Contact MICHAEL LEIGH
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/08/2016
Decision Date 06/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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