Vitalograph Ireland, Ltd. 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
Model 9160 VitaloQUB510(k)May 25, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	May 25, 2023
Model 9100 PFT/DICO510(k)Jul 15, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 15, 2022
Vitalograph Model 6000 Alpha510(k)Jan 26, 2022Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jan 26, 2022