K213911 is an FDA 510(k) clearance for the Microstream CO2 NanoPod. This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Covidien, LLC (Boulder, US). The FDA issued a Cleared decision on July 29, 2022, 226 days after receiving the submission on December 15, 2021.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K213911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2021 |
| Decision Date | July 29, 2022 |
| Days to Decision | 226 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 |