K261011
- 510(k) number
- K261011
- Device name
- Sleep Apnea Feature (v2.0)
- Applicant
- Samsung Electronics Co., Ltd. KR
- Product code
- QZW — Over-The-Counter Device To Assess Risk Of Sleep Apne
- Decision date
- 2026-07-20
- Date received
- 2026-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K261011.pdf
Official FDA record: K261011
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.