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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 K842381
Device Name SLS 3500 LED VISUAL STIMULATOR
Applicant
Nihon Kohden America, Inc.
1652 Deere Ave.
Irvine,  CA  92714
Applicant Contact PAUL M PARASHAK
Correspondent
Nihon Kohden America, Inc.
1652 Deere Ave.
Irvine,  CA  92714
Correspondent Contact PAUL M PARASHAK
Regulation Number882.1890
Classification Product Code
GWE  
Date Received06/18/1984
Decision Date 11/09/1984
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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