510(k) K261494

Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730) by Shanghai Hulu Devices Co., Ltd. — Product Code DQD

K261494 is an FDA 510(k) premarket notification submitted by Shanghai Hulu Devices Co., Ltd. for the device "Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)". The FDA issued a decision of Substantially Equivalent on July 31, 2026. The device falls under product code DQD (Stethoscope, Electronic), a Class II device regulated under 21 CFR 870.1875. Shanghai Hulu Devices Co., Ltd. has at least 2 other 510(k) clearances on record.