myAir
K-Number: K251889 · 2026-04-08
ApplicantResmed Corp
Decision Date2026-04-08
Product CodeMNS
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
myAir is a medical device manufactured by Resmed Corp. It received FDA 510(k) clearance on 2026-04-08 under approval number K251889. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the myAir?
myAir is a medical device that received FDA 510(k) clearance on 2026-04-08. It is manufactured by Resmed Corp. The 510(k) number is K251889.
When was myAir approved by the FDA?
myAir received FDA 510(k) clearance on 2026-04-08, under approval number K251889.
What company makes myAir?
myAir is manufactured by Resmed Corp.
What is the FDA product code for myAir?
The FDA product code for myAir is MNS. This falls under the Neurology category.
Other Devices by Resmed Corp
Related Devices (Code: MNS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.