K131386 is an FDA 510(k) clearance for the EZ-OX PLUS GENERATION II. This device is classified as a Cylinder, Compressed Gas, And Valve (Class I - General Controls, product code ECX).
Submitted by Air Liquide Healthcare America (Houston, US). The FDA issued a Cleared decision on March 14, 2014, 304 days after receiving the submission on May 14, 2013.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.
| 510(k) Number | K131386 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2013 |
| Decision Date | March 14, 2014 |
| Days to Decision | 304 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | ECX — Cylinder, Compressed Gas, And Valve |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.2700 |