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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 the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare Limited. It received FDA 510(k) clearance on 2021-12-10 under 510(k) 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. The listed applicant is Fisher & Paykel Healthcare Limited. The 510(k) number is K211560.

When did Airvo Nebulizer Adapter receive FDA 510(k) clearance?

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

Who is the listed applicant for Airvo Nebulizer Adapter?

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

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

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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