Resmed Pty Ltd (Registration Number: 3004604967) 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
AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System510(k)Sep 24, 2024Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Sep 24, 2024
Oran Park Mask510(k)Oct 19, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Oct 19, 2023
Whitsundays Mask System510(k)Jul 6, 2023Anesthesiology	Anesthesiology	510(k)Substantially Equivalent (Traditional)	Jul 6, 2023