AirLife Adult Heated Wire BiPAP/NIV Circuit
K-Number: K170378 · 2017-09-14
ApplicantVyaire Medical
Decision Date2017-09-14
Product CodeBZE
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
AirLife Adult Heated Wire BiPAP/NIV Circuit is a medical device manufactured by Vyaire Medical. It received FDA 510(k) clearance on 2017-09-14 under approval number K170378. 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 Adult Heated Wire BiPAP/NIV Circuit?
AirLife Adult Heated Wire BiPAP/NIV Circuit is a medical device that received FDA 510(k) clearance on 2017-09-14. It is manufactured by Vyaire Medical. The 510(k) number is K170378.
When was AirLife Adult Heated Wire BiPAP/NIV Circuit approved by the FDA?
AirLife Adult Heated Wire BiPAP/NIV Circuit received FDA 510(k) clearance on 2017-09-14, under approval number K170378.
What company makes AirLife Adult Heated Wire BiPAP/NIV Circuit?
AirLife Adult Heated Wire BiPAP/NIV Circuit is manufactured by Vyaire Medical.
What is the FDA product code for AirLife Adult Heated Wire BiPAP/NIV Circuit?
The FDA product code for AirLife Adult Heated Wire BiPAP/NIV Circuit is BZE.
Related Clinical Trials
Other Devices by Vyaire Medical
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K173280Neonatal ConchaSmart Breathing CircuitsTeleflexmedical, 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.