K021576 is an FDA 510(k) clearance for the MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370. 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 November 4, 2002, 174 days after receiving the submission on May 14, 2002.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K021576 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2002 |
| Decision Date | November 04, 2002 |
| Days to Decision | 174 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 |