Regulatory filing
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.
fda de novo · active · decided 2024-01-01
Machine-readable surfaces
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- Revision history: /regulatory-filings/samsung-galaxy-watch-fda-de-novo-den230041/history
- Data documentation: /data
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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
Covered models (1)
Sources (1)
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Identity
57ed262f-5b46-46a8-a427-ad5c1ea2a27c