K143060 is an FDA 510(k) clearance for the Intelli-Ox. This device is classified as a Cylinder, Compressed Gas, And Valve (Class I - General Controls, product code ECX).
Submitted by Air Liquide Healthcare (Houston, US). The FDA issued a Cleared decision on May 21, 2015, 209 days after receiving the submission on October 24, 2014.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.
| 510(k) Number | K143060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2014 |
| Decision Date | May 21, 2015 |
| Days to Decision | 209 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 |