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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 K942965
Device Name COMPUTER DYNO/GONIO/MYO GRAPHY
Applicant
INFOTRONIC MEDICAL ENGINEERING
523 BENFIELD RD.
SEVERNA PARK,  MD  21146
Applicant Contact KEES SMEEHUYZEN
Correspondent
INFOTRONIC MEDICAL ENGINEERING
523 BENFIELD RD.
SEVERNA PARK,  MD  21146
Correspondent Contact KEES SMEEHUYZEN
Regulation Number890.1375
Classification Product Code
IKN  
Subsequent Product Codes
IKE   KQX  
Date Received06/24/1994
Decision Date 10/07/1995
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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