K192446 is an FDA 510(k) clearance for the CO2 Mainstream Module. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Beijing Kingst Commercial & Trade Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on May 21, 2020, 258 days after receiving the submission on September 6, 2019.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K192446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2019 |
| Decision Date | May 21, 2020 |
| Days to Decision | 258 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 |