FDA 510(k) Application Details - K171503

Device Classification Name Catheter, Recording, Electrode, Reprocessed

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510(K) Number K171503
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 Amy Stoklas-Oakes
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Regulation Number 870.1220

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Classification Product Code NLH
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Date Received 05/23/2017
Decision Date 10/05/2017
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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