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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K855232
Device Name SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
Applicant
Neuroscience, Inc.
210 Topaz St.
Milpitas,  CA  95035
Applicant Contact JOHN P WALKER
Correspondent
Neuroscience, Inc.
210 Topaz St.
Milpitas,  CA  95035
Correspondent Contact JOHN P WALKER
Regulation Number882.1870
Classification Product Code
GWF  
Date Received12/30/1985
Decision Date 07/03/1986
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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