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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K160967
Device Name Finapres Nova Noninvasive Hemodynamic Monitor
Applicant
FINAPRES MEDICAL SYSTEMS BV
hogehilweg 8
amsterdam,  NL 1101 cc
Applicant Contact ir. iris van uitert
Correspondent
FINAPRES MEDICAL SYSTEMS BV
institutenweg 25,
7521 ph
enschede,  NL
Correspondent Contact ir. iris van uitert
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DSB  
Date Received04/06/2016
Decision Date 04/18/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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