Fifth Eye, Inc. FDA Approvals

0 new drug approvals and 3 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
AHI System510(k)Jul 14, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 14, 2022
AHI System510(k)Dec 3, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 3, 2021
Analytic for Hemodynamic Instability (AHI)510(k)Mar 1, 2021Cardiovascular	Cardiovascular	510(k)Unknown (Direct)	Mar 1, 2021