Guangdong Genial Technology Co., Ltd. FDA Approvals

0 new drug approvals and 5 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
Wearable Digital Thermometer (T31)510(k)Oct 30, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 30, 2024
Digital Thermometer, Model T28, T28L510(k)Jan 31, 2024General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 31, 2024
Digital Blood Pressure Monitor510(k)Nov 28, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 28, 2023
Digital Blood Pressure Monitor (Arm Type)510(k)Nov 22, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 22, 2023
Finger Clip Pulse Oximeter510(k)Oct 31, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 31, 2023