Resmed Pty Ltd (Registration Number: 3004604967)
AustraliaFDA applicant, unverified
- Devices
- 3
What Resmed Pty Ltd (Registration Number: 3004604967) makes
Resmed manufactures continuous positive airway pressure (CPAP) and non-invasive ventilation mask systems, including single-use and reusable designs for respiratory therapy. Their portfolio includes nasal masks, full-face masks, and hybrid systems tailored for sleep apnea and other respiratory conditions.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Whitsundays Mask System Ref K223747
Regimes: 510(k) Registry: 510(k)Oran Park Mask Ref K230476
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Resmed Pty Ltd (Registration Number: 3004604967) have in the registry?
The registry currently lists 3 devices for Resmed Pty Ltd (Registration Number: 3004604967). Devices recorded under merged duplicate company entries are counted once.
Which registries list Resmed Pty Ltd (Registration Number: 3004604967)'s devices?
Among its 3 most recently registered devices, Resmed Pty Ltd (Registration Number: 3004604967) has devices listed in FDA 510(k) (3 devices).
What risk classes do Resmed Pty Ltd (Registration Number: 3004604967)'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Resmed Pty Ltd (Registration Number: 3004604967)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Resmed Pty Ltd (Registration Number: 3004604967) in the registry?
The most recently registered devices listed for Resmed Pty Ltd (Registration Number: 3004604967) include AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System, Whitsundays Mask System and Oran Park Mask.