Healcerion 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
SONON Ultrasound Imaging System, Model: SONON300C510(k)May 16, 2022Radiology	Radiology	510(k)Substantially Equivalent (Special)	May 16, 2022
SONON Ultrasound Imaging System, Model: SONON 500L510(k)Apr 22, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Apr 22, 2022