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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 K844616
Device Name SIEGEN VISUAL STIMULATOR
Applicant
Siegen Corp.
2400 Bayshore Frontage Rd.
Mountain View,  CA  94043
Applicant Contact CAPERS W MCDONALD
Correspondent
Siegen Corp.
2400 Bayshore Frontage Rd.
Mountain View,  CA  94043
Correspondent Contact CAPERS W MCDONALD
Regulation Number882.1890
Classification Product Code
GWE  
Date Received11/27/1984
Decision Date 02/14/1985
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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