{"id":"26929e32-4969-49d7-8848-9df54fcab6a8","slug":"fda-den180044-apple-watch-ecg","filingNumber":"DEN180044","filingType":"fda_de_novo","jurisdiction":"us_fda","applicantCompanyId":"9d5d53e7-65ec-4e6c-80e0-86c94bff0f48","filingDate":"2018-08-14T12:00:00.000Z","decisionDate":"2018-09-11T12:00:00.000Z","status":"granted","clearanceScope":"De Novo authorization for the Apple Watch ECG app (single-lead electrocardiogram) to detect atrial fibrillation; granted September 2018.","sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180044","title":"FDA De Novo DEN180044 - Apple Watch ECG app","sourceName":"FDA De Novo Database (primary)"}],"verificationPosture":"verified","capFlagNotes":null,"relatedIncidentId":null,"reviewStatus":"reviewed","deprecatedAt":null,"deprecationReason":null,"createdAt":"2026-06-04T23:08:17.939Z","updatedAt":"2026-06-05T15:35:50.592Z","applicantCompany":{"id":"9d5d53e7-65ec-4e6c-80e0-86c94bff0f48","slug":"apple","name":"Apple"},"modelLinks":[{"id":"c2a7ff36-ab7a-4aef-85ba-1bef3dda6d2e","modelId":"7af0d52f-fb71-4b04-88e9-413ec552cb52","regulatoryFilingId":"26929e32-4969-49d7-8848-9df54fcab6a8","createdAt":"2026-06-04T23:08:18.255Z","model":{"slug":"apple-watch","modelName":"Apple Watch"}}]}