Intelli-Ox
FDA 510(k) K143060 · Air Liquide Healthcare
510(k) numberK143060
Submission
- Device name
- Intelli-Ox
- Applicant
- Air Liquide Healthcare
Houston, TX, US - Received
- October 24, 2014
- Decision date
- May 21, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K161179 | Intelli-OxECX · Traditional | Air Liquide Healthcare America Corporation | 04/13/2017SE |
| K161472 | Walk-O2-BoutECX · Traditional | Essex Industries, Inc. | 11/18/2016SE |
| K153518 | Medipure Oxygen-LC SystemECX · Special | Praxair Distribution, Incorporated. | 06/03/2016SE |
| K142149 | Oxytote Infinity Series Vipr SystemsECX · Traditional | Western/Scott Fetzer Co. | 04/17/2015SE |
| K132778 | Grab 'N Go Plus, Grab 'N Go DigitalECX · Traditional | Praxair Healthcare Services | 07/07/2014SE |
| K131386 | Ez-Ox Plus Generation IIECX · Traditional | Air Liquide Healthcare America | 03/14/2014SE |
| K101792 | Liv Linde Intergrated Valve-Portable Oxygen System, Model M706ECX · Traditional | Linde Gas North America, LLC | 03/18/2011SE |
| K063354 | Linde Integrated Valve (Liv)ECX · Traditional | Linde Gas Therapeutics | 04/17/2007SE |
| K062300 | Ox-Sox, Model C, D, E,ECX · Traditional | Pattient Safety Innovations, Llp | 11/27/2006SE |
| K053117 | Ez-Ox PlusECX · Traditional | Air Liquide Healthcare America | 04/10/2006SE |
Questions and answers
When was Intelli-Ox cleared by the FDA?
Intelli-Ox (K143060) received a 510(k) decision of Substantially Equivalent on May 21, 2015, 209 days after the submission was received.
What is the product code of K143060?
The FDA product code is ECX – Cylinder, Compressed Gas, And Valve, a Class I (low risk) device regulated under 21 CFR 868.2700.