FDA 510(k) Application Details - K153153

Device Classification Name Catheter, Recording, Electrode, Reprocessed

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510(K) Number K153153
Device Name Catheter, Recording, Electrode, Reprocessed
Applicant INNOVATIVE HEALTH, LLC
1435 NORTH HAYDEN ROAD, SUITE 100
SCOTTSDALE, AZ 85257 US
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Contact RAFAL CHUDZIK
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Regulation Number 870.1220

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Classification Product Code NLH
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Date Received 11/02/2015
Decision Date 03/14/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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