Compai Healthcare (Suzhou) 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
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)510(k)Apr 24, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 24, 2023
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)510(k)Apr 24, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 24, 2023