Regulatory filing
DEN180044 (us_fda)
De Novo authorization for the Apple Watch ECG app (single-lead electrocardiogram) to detect atrial fibrillation; granted September 2018.
fda de novo · granted · decided 2018-09-11
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-den180044-apple-watch-ecg.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/filings/26929e32-4969-49d7-8848-9df54fcab6a8
- Revision history: /regulatory-filings/fda-den180044-apple-watch-ecg/history
- Data documentation: /data
Key facts
- Jurisdiction
- us_fda
- Filing type
- fda de novo
- Status
- granted
- Filing number
- DEN180044
- Filing date
- 2018-08-14
- Decision date
- 2018-09-11
- Verification posture
- verified
Applicant
Covered models (1)
Sources (1)
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Identity
26929e32-4969-49d7-8848-9df54fcab6a8