K243956
- 510(k) number
- K243956
- Device name
- TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
- Applicant
- Nihon Kohden Corporation JP
- Product code
- CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Decision date
- 2025-06-10
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243956.pdf
Official FDA record: K243956
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.