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510(k) K243956

TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) by Nihon Kohden Corporation — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2025
Date Received
December 23, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

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