Cleared Traditional

WITHINGS BLOOD PRESSURE MONITOR

K110872 · Withings · Cardiovascular
May 2011
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K110872 is an FDA 510(k) clearance for the WITHINGS BLOOD PRESSURE MONITOR, a System, Measurement, Blood-pressure, Non-invasive (Class II — Special Controls, product code DXN), submitted by Withings (Hsin Chu City, TW). The FDA issued a Cleared decision on May 20, 2011, 52 days after receiving the submission on March 29, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1130.

Submission Details

510(k) Number K110872 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2011
Decision Date May 20, 2011
Days to Decision 52 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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