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FDA 510(k)

F&P myAirvo 3

K-Number: K222292 · 2024-05-08

Decision Date2024-05-08
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P myAirvo 3 is a medical device manufactured by Fisher & Paykel Healthcare. It received FDA 510(k) clearance on 2024-05-08 under approval number K222292. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P myAirvo 3?

F&P myAirvo 3 is a medical device that received FDA 510(k) clearance on 2024-05-08. It is manufactured by Fisher & Paykel Healthcare. The 510(k) number is K222292.

When was F&P myAirvo 3 approved by the FDA?

F&P myAirvo 3 received FDA 510(k) clearance on 2024-05-08, under approval number K222292.

What company makes F&P myAirvo 3?

F&P myAirvo 3 is manufactured by Fisher & Paykel Healthcare.

What is the FDA product code for F&P myAirvo 3?

The FDA product code for F&P myAirvo 3 is BTT.

Other Devices by Fisher & Paykel Healthcare

Related Devices (Code: BTT)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.