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FDA 510(k) Application Details - K160552
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
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510(K) Number
K160552
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
EDWARDS LIFESCIENCES, LLC
ONE EDWARDS WAY
Irvine, CA 92614 US
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Contact
Tara Viviani
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Regulation Number
870.1130
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Classification Product Code
DXN
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More FDA Info for this Product Code
Date Received
02/29/2016
Decision Date
06/01/2016
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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