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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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