Regulatory filing
DEN230041 (us_fda)
De Novo authorization for the Samsung Galaxy Watch sleep apnea feature (Samsung Health Monitor); granted February 2024.
fda de novo · granted · decided 2024-02-06
Machine-readable surfaces
- Markdown mirror: /regulatory-filings/fda-den230041-samsung-sleep-apnea.md
- JSON-LD: embedded in this page’s head
- REST API: /v1/filings/ad44aa3d-16a8-4802-b10f-be63f31f92b1
- Revision history: /regulatory-filings/fda-den230041-samsung-sleep-apnea/history
- Data documentation: /data
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
Covered models (1)
Sources (1)
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Identity
ad44aa3d-16a8-4802-b10f-be63f31f92b1