Sleep Apnea Feature (v2.0)— 510(k) K261011
Substantially EquivalentSamsung Electronics Co., Ltd.
FDA 510(k) clearance K261011 for Sleep Apnea Feature (v2.0), Substantially Equivalent on 2026-07-20. Applicant: Samsung Electronics Co., Ltd.. Device class: 2.
Summary
Samsung Electronics' Sleep Apnea Feature (v2.0) is filed under QZW, over-the-counter devices to assess risk of sleep apnea. The record doesn't describe the feature beyond its name and that code name.
Class II, 21 CFR 868.2378. Anesthesiology is both the classification panel and the review panel. It was a Traditional 510(k).
Samsung filed from Suwon-si, South Korea. Review took 116 calendar days (March 26 to July 20, 2026).
Clearance details
- Applicant
- Samsung Electronics Co., Ltd.
- Product code
- Product code QZW
- Device class
- Class 2
- Regulation
- 21 CFR 868.2378
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwon-Si, KR
Recent devices under product code QZW
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