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FDA 510(k) Application Details - K161393
Device Classification Name
Catheter, Recording, Electrode, Reprocessed
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510(K) Number
K161393
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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More FDA Info for this Product Code
Date Received
05/19/2016
Decision Date
10/26/2016
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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