Smart Wireless Stethoscope (4 models)— 510(k) K261494
Substantially EquivalentShanghai 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.
Summary
Shanghai Hulu Devices' Smart Wireless Stethoscope comes in four models (STEMO310, STEMO710, STEMO720, and STEMO730), filed under DQD, electronic stethoscopes. The record doesn't say how the models differ.
Class II, 21 CFR 870.1875. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Shanghai Hulu Devices filed from Shanghai, China. The decision came 86 calendar days after receipt (May 6 to July 31, 2026).
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
- Product code DQD
- Device class
- Class 2
- Regulation
- 21 CFR 870.1875
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shanghai, CN
Recent devices under product code DQD
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