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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 K943987
Device Name OPX-VX FEBEROPTIC INTRACRANIAL PRESSURE MONITORING CATHETER WITH DRAINAGE
Applicant
Innerspace Medical, Inc.
1923 SE Main St.
Irvine,  CA  92714
Applicant Contact NANCY E SHADFORTH
Correspondent
Innerspace Medical, Inc.
1923 SE Main St.
Irvine,  CA  92714
Correspondent Contact NANCY E SHADFORTH
Regulation Number882.1620
Classification Product Code
GWM  
Date Received08/16/1994
Decision Date 12/07/1994
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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