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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cranial Sound Monitor
510(k) Number K172892
Device Name Neuro Assessment System NAS-1000
Applicant
Headsense Medical, Inc.
520 S. Main St.
Suite 2457
Akron,  OH  44311
Applicant Contact Richard A. Lotti
Correspondent
Experien Group, LLC
224 Airport Pkwy., Suite 250
San Jose,  CA  95110
Correspondent Contact Kit Cariquitan
Regulation Number870.1875
Classification Product Code
QBE  
Date Received09/22/2017
Decision Date 03/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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