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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 K161010
Device Name HICP200 Patient/Monitor Interconnect Cable
Applicant
Innerspace Neuro Solutions, Inc.
1622 Edinger Ave. Suite C
Tustin,  CA  92780
Applicant Contact Gary G. Frugard
Correspondent
Innerspace Neuro Solutions, Inc.
1622 Edinger Ave. Suite C
Tustin,  CA  92780
Correspondent Contact Gary G. Frugard
Regulation Number882.1620
Classification Product Code
GWM  
Date Received04/11/2016
Decision Date 10/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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