ECX · Cylinder, Compressed Gas, And Valve
Anesthesiology · 21 CFR 868.2700 · Class 1
Overview
| Product Code | ECX |
|---|---|
| Device Name | Cylinder, Compressed Gas, And Valve |
| Regulation | 21 CFR 868.2700 |
| Device Class | Class 1 |
| Review Panel | Anesthesiology |
Identification
A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161179 | Intelli-Ox | Air Liquide Healthcare America Corporation | Apr 13, 2017 | SESE |
| K161472 | Walk-O2-Bout | Essex Industries, Inc. | Nov 18, 2016 | SESE |
| K153518 | Medipure Oxygen-LC System | Praxair Distribution, Incorporated. | Jun 3, 2016 | SESE |
| K143060 | Intelli-Ox | Air Liquide Healthcare | May 21, 2015 | SESE |
| K142149 | OXYTOTE INFINITY SERIES VIPR SYSTEMS | Western/Scott Fetzer Co. | Apr 17, 2015 | SESE |
| K132778 | GRAB 'N GO PLUS, GRAB 'N GO DIGITAL | Praxair Healthcare Services | Jul 7, 2014 | SESE |
| K131386 | EZ-OX PLUS GENERATION II | Air Liquide Healthcare America | Mar 14, 2014 | SESE |
| K101792 | LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 | Linde Gas North America, LLC | Mar 18, 2011 | SESE |
| K063354 | LINDE INTEGRATED VALVE (LIV) | Linde Gas Therapeutics | Apr 17, 2007 | SESE |
| K062300 | OX-SOX, MODEL C, D, E, | Pattient Safety Innovations, Llp | Nov 27, 2006 | SESE |
| K053117 | EZ-OX PLUS | Air Liquide Healthcare America | Apr 10, 2006 | SESE |
| K033897 | MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM | Aga-Linde Health Care | Jul 19, 2004 | SESE |
| K771246 | ALARM SYS FOR NITROUS OXIDE SYS. | Star Dental Mfg. Co. | Jul 15, 1977 | SESE |
Top Applicants
- Air Liquide Healthcare America — 2 clearances
- Western/Scott Fetzer Co. — 1 clearance
- Star Dental Mfg. Co. — 1 clearance
- Praxair Healthcare Services — 1 clearance
- Praxair Distribution, Incorporated. — 1 clearance
