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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 K843253
Device Name EMG/NCV & EVOKED RESPONSE, DESIGN W/
Applicant
Neurodiagnostics, Inc.
111 W. Dyer Rd.
Suite F
Santa Ana,  CA  92707
Correspondent
Neurodiagnostics, Inc.
111 W. Dyer Rd.
Suite F
Santa Ana,  CA  92707
Regulation Number882.1870
Classification Product Code
GWF  
Date Received08/20/1984
Decision Date 11/20/1984
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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