FDA 510(k) Application Details - K973355

Device Classification Name Electromyograph, Diagnostic

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510(K) Number K973355
Device Name Electromyograph, Diagnostic
Applicant ADVANTAGE MEDICAL DIVISION OF CME TELEMETRIX
100 COLLIP CIRCLE, #100
LONDON N6G 4X8 CA
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Contact ROBERT SNOW
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Regulation Number 890.1375

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Classification Product Code IKN
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Date Received 09/08/1997
Decision Date 12/05/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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