Cath Vision Aps 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
ECGenius System510(k)Aug 4, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 4, 2023
ECGenius System510(k)May 3, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 3, 2022