{"id":"2c30913a-09cf-4ce3-9382-05901dbbfeda","slug":"apple-watch-fda-de-novo-den180044","filingNumber":"DEN180044","filingType":"fda_de_novo","jurisdiction":"us_fda","applicantCompanyId":"9d5d53e7-65ec-4e6c-80e0-86c94bff0f48","filingDate":"2018-01-01T00:00:00.000Z","decisionDate":"2018-09-11T00:00:00.000Z","status":"active","clearanceScope":"FDA De Novo DEN180044 for Apple Watch ECG (2018). Also K240929 for sleep apnea (2024), K250507 for hypertension (2025). SpO2 NOT cleared (wellness-only).","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN180044","title":"DEN180044 De Novo","sourceName":"FDA De Novo Database"}],"verificationPosture":"verified","capFlagNotes":"SpO2 NOT cleared, wellness-only. Honest absence.","relatedIncidentId":null,"reviewStatus":"unreviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-07-15T02:26:32.697Z","updatedAt":"2026-07-15T02:26:32.697Z","applicantCompany":{"id":"9d5d53e7-65ec-4e6c-80e0-86c94bff0f48","slug":"apple","name":"Apple"},"modelLinks":[{"id":"af1d5686-3a26-49b4-bdbd-18e27d253fa7","modelId":"7af0d52f-fb71-4b04-88e9-413ec552cb52","regulatoryFilingId":"2c30913a-09cf-4ce3-9382-05901dbbfeda","createdAt":"2026-07-15T02:26:33.570Z","model":{"slug":"apple-watch","modelName":"Apple Watch"}}]}