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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K935368
Device Name STC DIAGNOSTIC 8000
Applicant
Sherman Technology Corp.
P.O. Box 691773
Los Angeles,  CA  90069
Applicant Contact DANIEL A SHERMAN
Correspondent
Sherman Technology Corp.
P.O. Box 691773
Los Angeles,  CA  90069
Correspondent Contact DANIEL A SHERMAN
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
IKE   KQX  
Date Received11/04/1993
Decision Date 05/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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