Ontact Health 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
Sonix Health510(k)Nov 27, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Nov 27, 2024
Sonix Health510(k)Oct 20, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Oct 20, 2023