Ox-Sox, Model C, D, E,

FDA 510(k) K062300 · Pattient Safety Innovations, Llp

Substantially Equivalent

510(k) numberK062300

Submission

Device name
Ox-Sox, Model C, D, E,
Applicant
Pattient Safety Innovations, Llp
Howell, MI, US
Received
August 8, 2006
Decision date
November 27, 2006
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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
K161472Walk-O2-BoutECX · Traditional Essex Industries, Inc.11/18/2016SE
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
K053117Ez-Ox PlusECX · Traditional Air Liquide Healthcare America04/10/2006SE

Questions and answers

When was Ox-Sox, Model C, D, E, cleared by the FDA?

Ox-Sox, Model C, D, E, (K062300) received a 510(k) decision of Substantially Equivalent on November 27, 2006, 111 days after the submission was received.

What is the product code of K062300?

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