Cleared Traditional

Withings Scan Monitor 2.0

K230812 · Withings · Cardiovascular
Aug 2023
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K230812 is an FDA 510(k) clearance for the Withings Scan Monitor 2.0, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Withings (Issy-Les-Moulineaux, FR). The FDA issued a Cleared decision on August 23, 2023, 152 days after receiving the submission on March 24, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K230812 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2023
Decision Date August 23, 2023
Days to Decision 152 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340