K243956 is an FDA 510(k) clearance for the TG-980P CO2 Sensor Kit (TG-980P). This device is classified as a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II - Special Controls, product code CCK).
Submitted by Nihon Kohden Corporation (Tokyo, JP). The FDA issued a Cleared decision on June 10, 2025, 169 days after receiving the submission on December 23, 2024.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1400.
| 510(k) Number | K243956 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2024 |
| Decision Date | June 10, 2025 |
| Days to Decision | 169 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 |