K161179 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 America Corporation (Houston, US). The FDA issued a Cleared decision on April 13, 2017, 352 days after receiving the submission on April 26, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.
| 510(k) Number | K161179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2016 |
| Decision Date | April 13, 2017 |
| Days to Decision | 352 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 |