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FDA 510(k)

F&P myAirvo 3

K-Number: K222292 · 2024-05-08

ApplicantFisher & Paykel Healthcare
Decision Date2024-05-08
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P myAirvo 3 is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare. It received FDA 510(k) clearance on 2024-05-08 under 510(k) 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. The listed applicant is Fisher & Paykel Healthcare. The 510(k) number is K222292.

When did F&P myAirvo 3 receive FDA 510(k) clearance?

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

Who is the listed applicant for F&P myAirvo 3?

The FDA 510(k) record lists Fisher & Paykel Healthcare as the applicant. This does not by itself establish the device manufacturer.

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

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

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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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