FDA.report

510(k) K243956

Device
TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
Applicant
Nihon Kohden Corporation
510(k) number
K243956
Product code
CCK
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-10
Date received
2024-12-23
Regulation
868.1400
Classification name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Sandra Gadeyne
Address
1-31-4 Nishiochiai, Shinjuku-Ku Tokyo JP 161-8560 161-8560

FDA Registration Numbers

Source Documents

510(k) summary PDF

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