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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 K110872
Device Name WITHINGS BLOOD PRESSURE MONITOR
Applicant
WITHINGS
NO.58, FU CHIUN STREET
hsin chu city,  TW 30067
Applicant Contact jen ke-min
Correspondent
WITHINGS
NO.58, FU CHIUN STREET
hsin chu city,  TW 30067
Correspondent Contact jen ke-min
Regulation Number870.1130
Classification Product Code
DXN  
Date Received03/29/2011
Decision Date 05/20/2011
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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