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Is ResMed AirView FDA approved or cleared?

Yes. ResMed AirView by ResMed Ltd. is named in the FDA register with a 510(k) clearance, latest decision in 2015.

In the EU: CE class IIa, found in EUDAMED. The manufacturer holds a valid notified body certificate under the MDR in EUDAMED.

At a glance

ProductResMed AirView
MakerResMed Ltd.
Care areaSleep & breathing
What it doesResMed cloud platform for clinicians to monitor CPAP and other sleep therapy devices remotely
FDA510(k), latest decision 2015
Verification levelExact product named in the FDA record (checked 18 October 2026)
EU (CE)Class IIa
EU certificateManufacturer certificate from a notified body (MDR) in EUDAMED (checked 18 October 2026)
Websiteresmed.com
StatusFDA verified
Last checked6 October 2026

Certification status can change. Always confirm in the official register before relying on it: the FDA databases, EUDAMED or the BfArM DiGA directory.

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