{"id":"ad44aa3d-16a8-4802-b10f-be63f31f92b1","slug":"fda-den230041-samsung-sleep-apnea","filingNumber":"DEN230041","filingType":"fda_de_novo","jurisdiction":"us_fda","applicantCompanyId":"98473e95-cf04-4165-ba07-fb53f1e9969b","filingDate":"2023-05-31T12:00:00.000Z","decisionDate":"2024-02-06T12:00:00.000Z","status":"granted","clearanceScope":"De Novo authorization for the Samsung Galaxy Watch sleep apnea feature (Samsung Health Monitor); granted February 2024.","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230041","title":"FDA De Novo DEN230041 - Samsung sleep apnea feature","sourceName":"FDA De Novo Database (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:08:21.502Z","updatedAt":"2026-06-05T15:35:50.829Z","applicantCompany":{"id":"98473e95-cf04-4165-ba07-fb53f1e9969b","slug":"samsung","name":"Samsung Electronics"},"modelLinks":[{"id":"67621640-e067-41ec-9c40-64ace3948592","modelId":"df95c54f-78bf-4e3d-a232-80c8385c6e1d","regulatoryFilingId":"ad44aa3d-16a8-4802-b10f-be63f31f92b1","createdAt":"2026-06-04T23:08:21.658Z","model":{"slug":"samsung-galaxy-watch","modelName":"Samsung Galaxy Watch (and Galaxy Ring)"}}]}