Submission Details
| 510(k) Number | K243956 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
Jun 2025
Decision
169d
Days
Class 2
Risk
About This 510(k) Submission
K243956 is an FDA 510(k) clearance for the TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1), 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 review panel. Regulated under 21 CFR 868.1400.
Device Classification
| Product Code | CCK — Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 868.1400 |
Manufacturer
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