Cleared Traditional

WITHINGS BLOOD PRESURE MONITOR

K133125 · Withings · Cardiovascular
Mar 2014
Decision
175d
Days
Class 2
Risk

About This 510(k) Submission

K133125 is an FDA 510(k) clearance for the WITHINGS BLOOD PRESURE MONITOR, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Withings (Issy Les Moulineaux, FR). The FDA issued a Cleared decision on March 24, 2014, 175 days after receiving the submission on September 30, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K133125 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2013
Decision Date March 24, 2014
Days to Decision 175 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXN — System, Measurement, Blood-pressure, Non-invasive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1130

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