FDA 510(k) Application Details - K972419

Device Classification Name Electromyograph, Diagnostic

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510(K) Number K972419
Device Name Electromyograph, Diagnostic
Applicant ERICH JAEGER, INC.
LEIBNIZSTRABE 7
D-97204
HOECHBERG, GERMANY DE
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Contact D. GROTHEER
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Regulation Number 890.1375

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Classification Product Code IKN
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Date Received 06/27/1997
Decision Date 04/30/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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