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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 K853864
Device Name INTRACRANIAL PRESSURE MONITORING KIT 070
Applicant
Camino Laboratories, Inc.
5955 Pacific Center Blvd.
San Diego,  CA  92121
Applicant Contact DAN MCKAY
Correspondent
Camino Laboratories, Inc.
5955 Pacific Center Blvd.
San Diego,  CA  92121
Correspondent Contact DAN MCKAY
Regulation Number882.1620
Classification Product Code
GWM  
Date Received09/17/1985
Decision Date 02/20/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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