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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K844566
Device Name ICP MONITOR MODEL 1000
Applicant
ADVANCED ULTRASONIC TESTING & RESEARCH CORP.
4305-40 ENTERPRISE DR.
SUITE A
WINSTON-SALEM,  NC  27106
Applicant Contact ROBERT P BRINKLEY
Correspondent
ADVANCED ULTRASONIC TESTING & RESEARCH CORP.
4305-40 ENTERPRISE DR.
SUITE A
WINSTON-SALEM,  NC  27106
Correspondent Contact ROBERT P BRINKLEY
Regulation Number882.1620
Classification Product Code
GWM  
Date Received11/23/1984
Decision Date 08/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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