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FDA 510(k)

myAir

K-Number: K241216 · 2024-09-26

ApplicantResmed Corp
Decision Date2024-09-26
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

myAir is a medical device manufactured by Resmed Corp. It received FDA 510(k) clearance on 2024-09-26 under approval number K241216. 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 2024-09-26. It is manufactured by Resmed Corp. The 510(k) number is K241216.

When was myAir approved by the FDA?

myAir received FDA 510(k) clearance on 2024-09-26, under approval number K241216.

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 K251657Personalized Therapy Comfort Settings (PTCS) K250624myAir K251889myAir

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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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