Walk-O2-Bout

FDA 510(k) K161472 · Essex Industries, Inc.

Substantially Equivalent

510(k) numberK161472

Submission

Device name
Walk-O2-Bout
Applicant
Essex Industries, Inc.
St. Louis, MO, US
Received
May 27, 2016
Decision date
November 18, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ECX – Cylinder, Compressed Gas, And Valve
Device class
Class I (low risk)
Regulation
21 CFR 868.2700
Specialty
Anesthesiology

Other 510(k)s with product code ECX

510(k)DeviceApplicantDecision
K161179Intelli-OxECX · Traditional Air Liquide Healthcare America Corporation04/13/2017SE
K153518Medipure Oxygen-LC SystemECX · Special Praxair Distribution, Incorporated.06/03/2016SE
K143060Intelli-OxECX · Traditional Air Liquide Healthcare05/21/2015SE
K142149Oxytote Infinity Series Vipr SystemsECX · Traditional Western/Scott Fetzer Co.04/17/2015SE
K132778Grab 'N Go Plus, Grab 'N Go DigitalECX · Traditional Praxair Healthcare Services07/07/2014SE
K131386Ez-Ox Plus Generation IIECX · Traditional Air Liquide Healthcare America03/14/2014SE
K101792Liv Linde Intergrated Valve-Portable Oxygen System, Model M706ECX · Traditional Linde Gas North America, LLC03/18/2011SE
K063354Linde Integrated Valve (Liv)ECX · Traditional Linde Gas Therapeutics04/17/2007SE
K062300Ox-Sox, Model C, D, E,ECX · Traditional Pattient Safety Innovations, Llp11/27/2006SE
K053117Ez-Ox PlusECX · Traditional Air Liquide Healthcare America04/10/2006SE

More from Air Liquide Healthcare America

510(k)DeviceDecision
K162811MR Conditional CGA 870CAN · Traditional 03/02/2017SE
K113767Mounted Medical Oxygen SystemBYJ · Traditional 06/29/2012SE
K101272Mass Oxygen Distribution System (Mods) Model 10C-0061-3BYJ · Traditional 08/20/2010SE

Questions and answers

When was Walk-O2-Bout cleared by the FDA?

Walk-O2-Bout (K161472) received a 510(k) decision of Substantially Equivalent on November 18, 2016, 175 days after the submission was received.

What is the product code of K161472?

The FDA product code is ECX – Cylinder, Compressed Gas, And Valve, a Class I (low risk) device regulated under 21 CFR 868.2700.