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FDA 510(k)

AirLife DuoTherm™ Humidification System

K-Number: K231380 · 2023-08-10

ApplicantVyaire Medical, Inc.
Decision Date2023-08-10
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirLife DuoTherm™ Humidification System is a medical device manufactured by Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2023-08-10 under approval number K231380. 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 AirLife DuoTherm™ Humidification System?

AirLife DuoTherm™ Humidification System is a medical device that received FDA 510(k) clearance on 2023-08-10. It is manufactured by Vyaire Medical, Inc.. The 510(k) number is K231380.

When was AirLife DuoTherm™ Humidification System approved by the FDA?

AirLife DuoTherm™ Humidification System received FDA 510(k) clearance on 2023-08-10, under approval number K231380.

What company makes AirLife DuoTherm™ Humidification System?

AirLife DuoTherm™ Humidification System is manufactured by Vyaire Medical, Inc..

What is the FDA product code for AirLife DuoTherm™ Humidification System?

The FDA product code for AirLife DuoTherm™ Humidification System is BTT.

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Related Devices (Code: BTT)

K160764AirLife Autofill Humidification ChamberCarefusion 2200, Inc. K161314FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASEFlexicare Medical Limited. K152029HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K161719Salter Labs Bubble HumidifierSalter Labs K163283HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010Hamilton Medical AG K162242Comfort Flo Humidification SystemTeleflexmedical, Inc.

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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