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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 K901732
Device Name EMG ACCESSORY FOR POSTUROGRAPHY
Applicant
NEUROCOM INTERNATIONAL, INC.
9570 S.E. LAWNFIELD RD.
CLACKAMAS,  OR  97015
Applicant Contact JACK FASSEL
Correspondent
NEUROCOM INTERNATIONAL, INC.
9570 S.E. LAWNFIELD RD.
CLACKAMAS,  OR  97015
Correspondent Contact JACK FASSEL
Regulation Number890.1375
Classification Product Code
IKN  
Date Received04/17/1990
Decision Date 09/10/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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