# DEN230041 (us_fda)

FDA De Novo DEN230041 for Samsung Galaxy Watch Sleep Apnea Feature (2024). Also K230292 for IRN (2023). US blood pressure NOT cleared.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_de_novo
- Status: active
- Filing number: DEN230041
- Filing date: 2024-01-01
- Decision date: 2024-01-01
- Verification posture: verified
- Cap-flag notes: US blood pressure NOT cleared. Honest absence.

## Applicant

- [Samsung Electronics](/companies/samsung.md)

## Covered models (1)

- [Samsung Galaxy Watch (and Galaxy Ring)](/models/samsung-galaxy-watch.md)

## Sources (1)

- [https://www.fda.gov/media/190467/download](https://www.fda.gov/media/190467/download)

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