FDA 510(k)

AirLife Infant Single Limb Heated Wire Circuit

K-Number: K151959 · 2016-01-20

Decision Date2016-01-20

Product CodeBZE

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

AirLife Infant Single Limb Heated Wire Circuit is a medical device manufactured by Carefusion, Inc.. It received FDA 510(k) clearance on 2016-01-20 under approval number K151959. The device is classified under product code BZE. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AirLife Infant Single Limb Heated Wire Circuit?

AirLife Infant Single Limb Heated Wire Circuit is a medical device that received FDA 510(k) clearance on 2016-01-20. It is manufactured by Carefusion, Inc.. The 510(k) number is K151959.

When was AirLife Infant Single Limb Heated Wire Circuit approved by the FDA?

AirLife Infant Single Limb Heated Wire Circuit received FDA 510(k) clearance on 2016-01-20, under approval number K151959.

What company makes AirLife Infant Single Limb Heated Wire Circuit?

AirLife Infant Single Limb Heated Wire Circuit is manufactured by Carefusion, Inc..

What is the FDA product code for AirLife Infant Single Limb Heated Wire Circuit?

The FDA product code for AirLife Infant Single Limb Heated Wire Circuit is BZE.

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Other Devices by Carefusion, Inc.

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Related Devices (Code: BZE)

K153234AirLife Adult Heated Wire CircuitCarefusion, Inc. K160540FLEXICARE NEONATAL HEATED WIRE BREATHING SYSTEMFlexicare Medical Limited. K151461Hybernite RTPlastiflex Group NV K151303AirLife Infant Heated Wire CircuitCare Fusion K170378AirLife Adult Heated Wire BiPAP/NIV CircuitVyaire Medical K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, Inc.

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.