Shanghai Hulu Devices Co., Ltd. FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)510(k)Jul 31, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 31, 2026
Smart Wireless Stethoscope510(k)May 23, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 23, 2022