{"id":"18746d05-3603-428e-88d2-5eb4baec8f42","slug":"fda-k201456-withings-scanwatch-ecg","filingNumber":"K201456","filingType":"fda_510k","jurisdiction":"us_fda","applicantCompanyId":"949b1fd6-4daa-4efb-9449-ac8c07c5c2d5","filingDate":"2020-06-01T12:00:00.000Z","decisionDate":"2021-10-05T12:00:00.000Z","status":"cleared","clearanceScope":"510(k) clearance for the Withings ScanWatch ECG and SpO2 functions; cleared 2021.","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201456","title":"FDA 510(k) K201456 - Withings ScanWatch ECG / SpO2","sourceName":"FDA 510(k) Database (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:09:21.052Z","updatedAt":"2026-06-05T15:35:46.291Z","applicantCompany":{"id":"949b1fd6-4daa-4efb-9449-ac8c07c5c2d5","slug":"withings","name":"Withings"},"modelLinks":[{"id":"07bd5f96-0aeb-43e6-97f9-326a858b9270","modelId":"7b714434-e448-4dd4-8302-98627a94db3b","regulatoryFilingId":"18746d05-3603-428e-88d2-5eb4baec8f42","createdAt":"2026-06-04T23:09:21.285Z","model":{"slug":"withings-scanwatch","modelName":"Withings ScanWatch"}}]}