K031411 is an FDA 510(k) clearance for the MINI STATCO2 CO2 DETECTOR, MODEL 10-55371. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Mercury Medical (Clearwater, US). The FDA issued a Cleared decision on July 30, 2003, 86 days after receiving the submission on May 5, 2003.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K031411 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 05, 2003 |
| Decision Date | July 30, 2003 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1400 |