Airlife Demand Nasal Cannula

FDA 510(k) K023673 · Allegiance Healthcare Corp.

Substantially Equivalent

510(k) numberK023673

Submission

Device name
Airlife Demand Nasal Cannula
Applicant
Allegiance Healthcare Corp.
Mcgaw Park, IL, US
Received
November 1, 2002
Decision date
May 2, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
NFB – Conserver, Oxygen
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5905
Specialty
Anesthesiology

Other 510(k)s with product code NFB

510(k)DeviceApplicantDecision
K250322Respond OC Conserving Regulator (130-0800)NFB · Traditional Responsive Respiratory07/24/2025SE
K220591ProximaNFB · Traditional Dynasthetics, LLC12/15/2022SE
K221014Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileNFB · Traditional Effortless Oxygen, LLC10/17/2022SE
K200401ApogeeNFB · Traditional Incoba Ltd D/B/A Dynaris11/14/2020SE
K151506Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaNFB · Traditional Salter Labs03/11/2016SE
K131023Theraflow Single Lumen and Theraflow Dual LumenNFB · Traditional Medical Products, LLC10/11/2013SE
K113111Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special Inovo, Inc.12/08/2011SE
K103392Chad Therapeutic Evolution Electronic Oxygen ConserverNFB · Special Inovo, Inc.12/17/2010SE
K090421Model 350G Gas ConserverNFB · Traditional Inspired Technologies, Inc.05/29/2009SE
K070740Chad Therapeutics Bonsai Model 800NFB · Special Chad Therapeutics, Inc.05/07/2007SE

More from Chad Therapeutics, Inc.

510(k)DeviceDecision
K023602Small Volume NebulizerCAF · Special 05/01/2003SE
K023419Trilaminate Drapes/TiburonKKX · Traditional 02/11/2003SE
K024120Modification to Temno Biopsy NeedlesFCG · Special 01/15/2003SE
K024292Modification to Positive Touch Powder-Free Latex Examination Gloves with Protein and…LYY · Special 01/09/2003SE
K024102Dental Powder-Free Latex Examination Gloves with Protein Labeling ClaimLYY · Special 12/18/2002SE
K023425Drapes with Absorbent ReinforcementKKX · Special 11/06/2002SE
K022765Nitrile Powder-Free Examination GlovesLZA · Traditional 10/11/2002SE
K023170Nitrile Powder-Free Examination GlovesLZA · Special 10/09/2002SE
K023167Breathable Surgical GownFYA · Special 10/02/2002SE
K012931Genesis Sterrad Compatible Reusable Sterilization Container SystemFRG · Traditional 08/20/2002SE

Questions and answers

When was Airlife Demand Nasal Cannula cleared by the FDA?

Airlife Demand Nasal Cannula (K023673) received a 510(k) decision of Substantially Equivalent on May 2, 2003, 182 days after the submission was received.

What is the product code of K023673?

The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.