510(k) K033897
- Device
- MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM
- Applicant
- AGA-LINDE HEALTH CARE
- 510(k) number
- K033897
- Product code
- ECX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2004-07-19
- Date received
- 2003-12-16
- Regulation
- 868.2700
- Classification name
- Cylinder, Compressed Gas, And Valve
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES JOCHEN ROGERS
- Address
- P.O. Box 391117 Solon OH US 44139 44139
FDA Registration Numbers#
- 3008791328
- 1937613
- 3008115001
- 3005380088
- 3034694958
- 3003764448
- 3005621729
- 2183615
- 3014810929
- 3023339109
- 3013846070
- 3012002722
- 3020188747
- 3008281139
- 3013530901
Source Documents#
Other 510(k) Records For Product Code ECX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161179 | Intelli-Ox | Air Liquide Healthcare America Corporation | 2017-04-13 |
| K161472 | Walk-O2-Bout | Essex Industries, Inc. | 2016-11-18 |
| K153518 | Medipure Oxygen-LC System | Praxair Distribution, Incorporated. | 2016-06-03 |
| K143060 | Intelli-Ox | Air Liquide Healthcare | 2015-05-21 |
| K142149 | OXYTOTE INFINITY SERIES VIPR SYSTEMS | Western/Scott Fetzer Co. | 2015-04-17 |
| K132778 | GRAB 'N GO PLUS, GRAB 'N GO DIGITAL | Praxair Healthcare Services | 2014-07-07 |
| K131386 | EZ-OX PLUS GENERATION II | Air Liquide Healthcare America | 2014-03-14 |
| K101792 | LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 | Linde Gas North America, LLC | 2011-03-18 |
| K063354 | LINDE INTEGRATED VALVE (LIV) | Linde Gas Therapeutics | 2007-04-17 |
| K062300 | OX-SOX, MODEL C, D, E, | Pattient Safety Innovations, Llp | 2006-11-27 |
| K053117 | EZ-OX PLUS | Air Liquide Healthcare America | 2006-04-10 |
| K771246 | ALARM SYS FOR NITROUS OXIDE SYS. | Star Dental Mfg. Co. | 1977-07-15 |
Legacy Summary#
summary
FDA Review#
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