FDA 510(k) Application Details - K090180

Device Classification Name Electrode, Electrocardiograph

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510(K) Number K090180
Device Name Electrode, Electrocardiograph
Applicant VERMED, INC.
9 LOVELL DR.
BELLOWS FALLS, VT 05101 US
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Contact MARC FILLION
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Regulation Number 870.2360

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Classification Product Code DRX
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Date Received 01/23/2009
Decision Date 06/17/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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