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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 K140312
Device Name EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM
Applicant
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Applicant Contact RENATE A MACLAREN
Correspondent
EDWARDS LIFESCIENCES, LLC.
ONE EDWARDS WAY
IRVINE,  CA  92614
Correspondent Contact RENATE A MACLAREN
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Code
DSB  
Date Received02/07/2014
Decision Date 06/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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