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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Photic, Evoked Response
510(k) Number K860910
Device Name V100 VISUALLY EVOKED POTENTIAL MONITOR
Applicant
New Potentials, Inc.
31 Wilkins St.
Hudson,  MA  01749
Applicant Contact SIWKO, PRES.
Correspondent
New Potentials, Inc.
31 Wilkins St.
Hudson,  MA  01749
Correspondent Contact SIWKO, PRES.
Regulation Number882.1890
Classification Product Code
GWE  
Date Received03/11/1986
Decision Date 12/18/1986
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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