Sleep Apnea Feature (v2.0)— 510(k) K261011

Name: FDA 510(k) clearance K261011
Creator: U.S. Food and Drug Administration
Published: 2026-07-20

Substantially Equivalent

Samsung 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.

Clearance details

Applicant: Samsung Electronics Co., Ltd.
Product code: Code QZW
Device class: Class 2
Regulation: 21 CFR 868.2378
Advisory panel: Anesthesiology
Date received: 2026-03-26
Decision date: 2026-07-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

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DEN230041 — Sleep Apnea Feature2024-02-06

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