Withings Scan Monitor 2.0— 510(k) K230812

Substantially Equivalent

Withings

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

Clearance details

Applicant: Withings
Product code: Code DPS
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 ↗

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.