FDA 510(k)

AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask

K-Number: K230915 · 2024-11-12

Decision Date2024-11-12

Product CodeCCK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask is a medical device manufactured by Vyaire Medical, Inc.. It received FDA 510(k) clearance on 2024-11-12 under approval number K230915. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask?

AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask is a medical device that received FDA 510(k) clearance on 2024-11-12. It is manufactured by Vyaire Medical, Inc.. The 510(k) number is K230915.

When was AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask approved by the FDA?

AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask received FDA 510(k) clearance on 2024-11-12, under approval number K230915.

What company makes AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask?

AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask is manufactured by Vyaire Medical, Inc..

What is the FDA product code for AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask?

The FDA product code for AirLife Open Et Oxygen Mask, AirLife Open Et+ Oxygen Mask is CCK.

Other Devices by Vyaire Medical, Inc.

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Related Devices (Code: CCK)

K162343Westmed Gas Sampling Cannula with O2 deliveryWestmed, Inc. K151421Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample LinesSalter Labs K172904IntelliVue Capnography Extension, IntelliVue Microstream ExtensionPhilips Medizin Systeme Boeblingen GmbH K171765Nihon Kohden CO2 MonitorNihon Kohden Corporation K171028CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessoriesGE Healthcare Finland Oy K161250OC-FLEX Flexible IntraOral CannulaVenture Therapeutics, 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.