Suzhou Peaksonic Medical Technology 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
Bladder Scanner, Model Name:M5510(k)Jul 1, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jul 1, 2022
Bladder Scanner (Model: M3, M3-HD, M4, M4-HD)510(k)Feb 26, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 26, 2021