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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Impedance Plethysmograph, Cranial
510(k) Number K182967
Device Name Visor System
Applicant
Cerebrotech Medical Systems, Inc.
1048 Serpentine Lane Suite 301
Pleasanton,  CA  94566
Applicant Contact Dawnel Scott
Correspondent
Cerebrotech Medical Systems, Inc.
1048 Serpentine Lane Suite 301
Pleasanton,  CA  94566
Correspondent Contact Dawnel Scott
Regulation Number870.2770
Classification Product Code
QAF  
Date Received10/26/2018
Decision Date 11/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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