# DEN180044 (us_fda)

FDA De Novo DEN180044 for Apple Watch ECG (2018). Also K240929 for sleep apnea (2024), K250507 for hypertension (2025). SpO2 NOT cleared (wellness-only).

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_de_novo
- Status: active
- Filing number: DEN180044
- Filing date: 2018-01-01
- Decision date: 2018-09-11
- Verification posture: verified
- Cap-flag notes: SpO2 NOT cleared, wellness-only. Honest absence.

## 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/pmn.cfm?ID=DEN180044](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=DEN180044)

_Canonical URL: /regulatory-filings/apple-watch-fda-de-novo-den180044. HTML version: [/regulatory-filings/apple-watch-fda-de-novo-den180044](/regulatory-filings/apple-watch-fda-de-novo-den180044)._