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FDA 510(k)

AirLife Autofill Humidification Chamber

K-Number: K160764 · 2016-08-25

ApplicantCarefusion 2200, Inc.
Decision Date2016-08-25
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirLife Autofill Humidification Chamber is a medical device manufactured by Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2016-08-25 under approval number K160764. 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 Autofill Humidification Chamber?

AirLife Autofill Humidification Chamber is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by Carefusion 2200, Inc.. The 510(k) number is K160764.

When was AirLife Autofill Humidification Chamber approved by the FDA?

AirLife Autofill Humidification Chamber received FDA 510(k) clearance on 2016-08-25, under approval number K160764.

What company makes AirLife Autofill Humidification Chamber?

AirLife Autofill Humidification Chamber is manufactured by Carefusion 2200, Inc..

What is the FDA product code for AirLife Autofill Humidification Chamber?

The FDA product code for AirLife Autofill Humidification Chamber is BTT.

Related Clinical Trials

NCT07515716 Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia NOT_YET_RECRUITING

Other Devices by Carefusion 2200, Inc.

K153554Genesis Low Temperature Reusable Rigid Container System K151036Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments K163615Snowden-Pencer MicroLap 3mm Laparoscopic Instruments K162432Multi-Link X2 ECG Cable and Lead Wire System K210324V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186

Related Devices (Code: BTT)

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. K162553AirSpiral Heated Breathing TubeFisher & Paykel Healthcare

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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