FDA 510(k) Application Details - K102610

Device Classification Name Electromyograph, Diagnostic

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510(K) Number K102610
Device Name Electromyograph, Diagnostic
Applicant TELEEMG, LLC USA
65 ARLINGTON ROAD
WOBURN, MA 01801 US
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Contact JOE F JABRE, M.D.
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Regulation Number 890.1375

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Classification Product Code IKN
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Date Received 09/10/2010
Decision Date 03/04/2011
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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