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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 the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2016-08-25 under 510(k) 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. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K160764.

When did AirLife Autofill Humidification Chamber receive FDA 510(k) clearance?

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

Who is the listed applicant for AirLife Autofill Humidification Chamber?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Carefusion 2200, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: BTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LPK251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)Fisher & Paykel Healthcare, Ltd.

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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