# DEN180044 (us_fda)

De Novo authorization for the Apple Watch ECG app (single-lead electrocardiogram) to detect atrial fibrillation; granted September 2018.

## 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

- [Apple](/companies/apple.md)

## Covered models (1)

- [Apple Watch](/models/apple-watch.md)

## Sources (1)

- [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180044](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180044)

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