# DEN230041 (us_fda)

De Novo authorization for the Samsung Galaxy Watch sleep apnea feature (Samsung Health Monitor); granted February 2024.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_de_novo
- Status: granted
- Filing number: DEN230041
- Filing date: 2023-05-31
- Decision date: 2024-02-06
- Verification posture: verified

## Applicant

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

## Covered models (1)

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

## Sources (1)

- [https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230041](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN230041)

_Canonical URL: /regulatory-filings/fda-den230041-samsung-sleep-apnea. HTML version: [/regulatory-filings/fda-den230041-samsung-sleep-apnea](/regulatory-filings/fda-den230041-samsung-sleep-apnea)._