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FDA 510(k) Application Details - K173916
Device Classification Name
System, Measurement, Blood-Pressure, Non-Invasive
More FDA Info for this Device
510(K) Number
K173916
Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Applicant
Finapres Medical Systems B.V.
Institutenweg 25
Enschede 7521 PH NL
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Contact
Iris van Uitert
Other 510(k) Applications for this Contact
Regulation Number
870.1130
More FDA Info for this Regulation Number
Classification Product Code
DXN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/22/2017
Decision Date
11/06/2018
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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