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FDA 510(k)

AireHealth NebulizerTM

K-Number: K201167 · 2020-12-03

ApplicantAirehealth, Inc.
Decision Date2020-12-03
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AireHealth NebulizerTM is a medical device manufactured by Airehealth, Inc.. It received FDA 510(k) clearance on 2020-12-03 under approval number K201167. 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 AireHealth NebulizerTM?

AireHealth NebulizerTM is a medical device that received FDA 510(k) clearance on 2020-12-03. It is manufactured by Airehealth, Inc.. The 510(k) number is K201167.

When was AireHealth NebulizerTM approved by the FDA?

AireHealth NebulizerTM received FDA 510(k) clearance on 2020-12-03, under approval number K201167.

What company makes AireHealth NebulizerTM?

AireHealth NebulizerTM is manufactured by Airehealth, Inc..

What is the FDA product code for AireHealth NebulizerTM?

The FDA product code for AireHealth NebulizerTM 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.

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