K112402 is an FDA 510(k) clearance for the ULTRAMAXO2 OXYGEN ANALYER. This device is classified as a Analyzer, Gas, Oxygen, Gaseous-phase (Class II - Special Controls, product code CCL).
Submitted by Maxtec, LLC (Salt Lake City, US). The FDA issued a Cleared decision on December 14, 2011, 114 days after receiving the submission on August 22, 2011.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1720.
| 510(k) Number | K112402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 2011 |
| Decision Date | December 14, 2011 |
| Days to Decision | 114 days |
| Submission Type | Abbreviated |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCL - Analyzer, Gas, Oxygen, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1720 |