FDA 510(k)

Airvo Nebulizer Adapter

K-Number: K211560 · 2021-12-10

ApplicantFisher & Paykel Healthcare Limited

Decision Date2021-12-10

Product CodeCAF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Airvo Nebulizer Adapter is a medical device manufactured by Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2021-12-10 under approval number K211560. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Airvo Nebulizer Adapter?

Airvo Nebulizer Adapter is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Fisher & Paykel Healthcare Limited. The 510(k) number is K211560.

When was Airvo Nebulizer Adapter approved by the FDA?

Airvo Nebulizer Adapter received FDA 510(k) clearance on 2021-12-10, under approval number K211560.

What company makes Airvo Nebulizer Adapter?

Airvo Nebulizer Adapter is manufactured by Fisher & Paykel Healthcare Limited.

What is the FDA product code for Airvo Nebulizer Adapter?

The FDA product code for Airvo Nebulizer Adapter is CAF.

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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.