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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 K871964
Device Name SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU.
Applicant
Siegen Corp.
538 Oakmead Pkwy.
Sunnyvale,  CA  94086
Applicant Contact BERT W MYERS
Correspondent
Siegen Corp.
538 Oakmead Pkwy.
Sunnyvale,  CA  94086
Correspondent Contact BERT W MYERS
Regulation Number882.1870
Classification Product Code
GWF  
Date Received05/20/1987
Decision Date 10/01/1987
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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