Withings Scan Monitor 2.0— 510(k) K230812

Name: FDA 510(k) clearance K230812
Creator: U.S. Food and Drug Administration
Published: 2023-08-23

Substantially Equivalent

Withings

FDA 510(k) clearance K230812 for Withings Scan Monitor 2.0, Substantially Equivalent on 2023-08-23. Applicant: Withings. Device class: 2.

Clearance details

Applicant: Withings
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 2023-03-24
Decision date: 2023-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issy-Les-Moulineaux, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code DPS

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K252463 — SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)2026-07-02
K251670 — MAC 7 Resting ECG Analysis System2026-01-26
K252361 — AccurECG Analysis System (v2.0)2025-12-22
K252474 — Withings BeamO (SCT02)2025-11-10
K250569 — Cardiologs Holter Platform2025-08-06

More clearances from Withings

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K240795 — Withings ECG App2025-06-15
K231667 — Withings Sleep Rx2024-09-06
K160544 — Withings Thermo (Model SCT01)2016-06-17
K133125 — WITHINGS BLOOD PRESURE MONITOR2014-03-24
K110872 — WITHINGS BLOOD PRESSURE MONITOR2011-05-20

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.