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FDA 510(k)

myAir

K-Number: K250624 · 2025-05-28

ApplicantResmed Corp
Decision Date2025-05-28
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

myAir is a medical device manufactured by Resmed Corp. It received FDA 510(k) clearance on 2025-05-28 under approval number K250624. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the myAir?

myAir is a medical device that received FDA 510(k) clearance on 2025-05-28. It is manufactured by Resmed Corp. The 510(k) number is K250624.

When was myAir approved by the FDA?

myAir received FDA 510(k) clearance on 2025-05-28, under approval number K250624.

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 BZD.

Other Devices by Resmed Corp

K200565Galapogos K241939EasyCare Tx 2 K241216myAir K251657Personalized Therapy Comfort Settings (PTCS) K251889myAir

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K160836Menai SystemResmed, Ltd. K161978AirFit N20Resmed, Ltd. K160127iCodeConnect3B Medical, Inc. K153505F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited K160822S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASVResmed, Ltd. K153387Luna CPAP and Auto CPAP System3B Medical, Inc.

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.

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