Guangzhou Berrcom Medical Device 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
Digital Thermometer, Model: DT007, DT008510(k)Jan 20, 2023General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 20, 2023
Digital thermometer, Model DT101, DT102510(k)Apr 5, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Apr 5, 2022
Ear Thermometer, Model ET005, ET008, ET009510(k)Feb 25, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 25, 2022
Ear Thermometer, Model ET001510(k)Feb 18, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Feb 18, 2022
Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311510(k)Jan 28, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Jan 28, 2022