FDA 510(k) Application Details - K984052

Device Classification Name Electromyograph, Diagnostic

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510(K) Number K984052
Device Name Electromyograph, Diagnostic
Applicant OXFORD INSTRUMENTS MEDICAL SYSTEMS
P.O. BOX 4341
CROFTON, MD 21114 US
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Contact E J SMITH
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Regulation Number 890.1375

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Classification Product Code IKN
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Date Received 11/13/1998
Decision Date 05/17/1999
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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