Echolight S.P.A 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
EchoSK and EchoSGyn modules for EchoS Family devices510(k)Mar 16, 2022Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 16, 2022
EchoS Family510(k)Feb 25, 2021Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Feb 25, 2021