Smart Wireless Stethoscope (4 models)— 510(k) K261494

Name: FDA 510(k) clearance K261494
Creator: U.S. Food and Drug Administration
Published: 2026-07-31

Substantially Equivalent

Shanghai Hulu Devices Co., Ltd.

FDA 510(k) clearance K261494 for Smart Wireless Stethoscope (4 models), Substantially Equivalent on 2026-07-31. Applicant: Shanghai Hulu Devices Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)
Applicant: Shanghai Hulu Devices Co., Ltd.
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 2026-05-06
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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