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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Electronic
510(k) Number K261494
Device Name Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)
Applicant
Shanghai Hulu Devices Co., Ltd.
# 525 N. Sichuan Rd.
Suite 2706
Shanghai,  CN 200085
Applicant Contact Junfeng Zhao
Correspondent
Shanghai Hulu Devices Co., Ltd.
# 525 N. Sichuan Rd.
Suite 2706
Shanghai,  CN 200085
Correspondent Contact Junfeng Zhao
Regulation Number870.1875
Classification Product Code
DQD  
Date Received05/06/2026
Decision Date 07/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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