Scan Monitor— 510(k) K201456

Substantially Equivalent

Withings SA

FDA 510(k) clearance K201456 for Scan Monitor, Substantially Equivalent on 2021-10-05. Applicant: Withings SA.

Clearance details

Applicant: Withings SA
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2020-06-01
Decision date: 2021-10-05
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.