Withings Thermo (Model SCT01)— 510(k) K160544

Substantially Equivalent

Withings

FDA 510(k) clearance K160544 for Withings Thermo (Model SCT01), Substantially Equivalent on 2016-06-17. Applicant: Withings.

Clearance details

Applicant: Withings
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2016-02-26
Decision date: 2016-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Issy-Les-Moulineaux, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.