{"id":"57ed262f-5b46-46a8-a427-ad5c1ea2a27c","slug":"samsung-galaxy-watch-fda-de-novo-den230041","filingNumber":"DEN230041","filingType":"fda_de_novo","jurisdiction":"us_fda","applicantCompanyId":"98473e95-cf04-4165-ba07-fb53f1e9969b","filingDate":"2024-01-01T00:00:00.000Z","decisionDate":"2024-01-01T00:00:00.000Z","status":"active","clearanceScope":"FDA De Novo DEN230041 for Samsung Galaxy Watch Sleep Apnea Feature (2024). Also K230292 for IRN (2023). US blood pressure NOT cleared.","sources":[{"url":"https://www.fda.gov/media/190467/download","title":"DEN230041 De Novo","sourceName":"FDA"}],"verificationPosture":"verified","capFlagNotes":"US blood pressure NOT cleared. Honest absence.","relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:26:39.584Z","updatedAt":"2026-07-15T02:26:39.584Z","applicantCompany":{"id":"98473e95-cf04-4165-ba07-fb53f1e9969b","slug":"samsung","name":"Samsung Electronics"},"modelLinks":[{"id":"f8b9601e-3553-45c6-900b-218e7e2c3c5e","modelId":"df95c54f-78bf-4e3d-a232-80c8385c6e1d","regulatoryFilingId":"57ed262f-5b46-46a8-a427-ad5c1ea2a27c","createdAt":"2026-07-15T02:26:40.473Z","model":{"slug":"samsung-galaxy-watch","modelName":"Samsung Galaxy Watch (and Galaxy Ring)"}}]}