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FDA 510(k)

AIRVO HUMIDIFIER MYAIRO HUMIDIFIER

K-Number: K121975 · 2013-01-03

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2013-01-03
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AIRVO HUMIDIFIER MYAIRO HUMIDIFIER is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2013-01-03 under 510(k) number K121975. 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 AIRVO HUMIDIFIER MYAIRO HUMIDIFIER?

AIRVO HUMIDIFIER MYAIRO HUMIDIFIER is a medical device that received FDA 510(k) clearance on 2013-01-03. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K121975.

When did AIRVO HUMIDIFIER MYAIRO HUMIDIFIER receive FDA 510(k) clearance?

AIRVO HUMIDIFIER MYAIRO HUMIDIFIER received FDA 510(k) clearance on 2013-01-03, under 510(k) number K121975.

Who is the listed applicant for AIRVO HUMIDIFIER MYAIRO HUMIDIFIER?

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

What is the FDA product code for AIRVO HUMIDIFIER MYAIRO HUMIDIFIER?

The FDA product code for AIRVO HUMIDIFIER MYAIRO HUMIDIFIER 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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