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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 K133125
Device Name WITHINGS BLOOD PRESURE MONITOR
Applicant
WITHINGS
20 RUE ROUGET DE LISLE
ISSY LES MOULINEAUX,  FR 92130
Applicant Contact JEN KE-MIN
Correspondent
WITHINGS
20 RUE ROUGET DE LISLE
ISSY LES MOULINEAUX,  FR 92130
Correspondent Contact JEN KE-MIN
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/30/2013
Decision Date 03/24/2014
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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