Intelli-Ox
FDA 510(k) clearance K143060 · decided 2015-05-21
Clearance details
- K-number
- K143060
- Device name
- Intelli-Ox
- Applicant
- Air Liquide Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2014-10-24
- Decision date
- 2015-05-21
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- ECX
- Device class
- 1
- Regulation number
- 868.2700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Intelli-Ox (K161179) | Air Liquide Healthcare America Corporation | 2017-04-13 |
| Walk-O2-Bout (K161472) | Essex Industries, Inc. | 2016-11-18 |
| Medipure Oxygen-LC System (K153518) | Praxair Distribution, Incorporated. | 2016-06-03 |
| OXYTOTE INFINITY SERIES VIPR SYSTEMS (K142149) | Western/Scott Fetzer Co. | 2015-04-17 |
| GRAB 'N GO PLUS, GRAB 'N GO DIGITAL (K132778) | Praxair Healthcare Services | 2014-07-07 |
| EZ-OX PLUS GENERATION II (K131386) | Air Liquide Healthcare America | 2014-03-14 |
| LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706 (K101792) | Linde Gas North America, LLC | 2011-03-18 |
| LINDE INTEGRATED VALVE (LIV) (K063354) | Linde Gas Therapeutics | 2007-04-17 |
| OX-SOX, MODEL C, D, E, (K062300) | Pattient Safety Innovations, Llp | 2006-11-27 |
| EZ-OX PLUS (K053117) | Air Liquide Healthcare America | 2006-04-10 |
| MEDICYL-E-LITE PORTABLE OXYGEN DELIVERY SYSTEM (K033897) | Aga-Linde Health Care | 2004-07-19 |
| ALARM SYS FOR NITROUS OXIDE SYS. (K771246) | Star Dental Mfg. Co. | 1977-07-15 |
Recalls involving this device
No recalls on record reference this clearance.