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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K922941
Device Name CLINICAL NEURO SYSTEMS MONITORR ICP VENTRICULAR CA
Applicant
CLINICAL NEURO SYSTEMS LLC.
875 NORMA WAY
SANTA BARBARA,  CA  93111
Applicant Contact STEPHEN W LAGUETTE
Correspondent
CLINICAL NEURO SYSTEMS LLC.
875 NORMA WAY
SANTA BARBARA,  CA  93111
Correspondent Contact STEPHEN W LAGUETTE
Regulation Number882.5550
Classification Product Code
JXG  
Date Received06/18/1992
Decision Date 08/26/1992
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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