Sleep Apnea Feature— 510(k) DEN230041

Unknown

Samsung Electronics Co., Ltd.

FDA 510(k) clearance DEN230041 for Sleep Apnea Feature, Unknown on 2024-02-06. 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: 2023-05-31
Decision date: 2024-02-06
Decision: Unknown
Clearance type: Direct
Location: Suwon-Si, KR

View on FDA.gov ↗

Recent devices under product code QZW

K261011 — Sleep Apnea Feature (v2.0)2026-07-20
K240929 — Sleep Apnea Notification Feature (SANF)2024-09-13

More clearances from Samsung Electronics Co., Ltd.

K260481 — GC85A2026-08-27
K261187 — Hearing Aid Feature2026-07-31
K242651 — GM852024-10-01
K242478 — GF85 (models GF85-3P, GF85-SP)2024-09-19
K240909 — Samsung ECG App v 1.3 (ECG)2024-08-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.