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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K243956
Device Name TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo,  JP 161-8560
Applicant Contact Sandra Gadeyne
Correspondent
Nihon Kohden America, LLC
15353 Barranca Pkwy.
Rvine,  CA  92618
Correspondent Contact Charlemagne Chua
Regulation Number868.1400
Classification Product Code
CCK  
Date Received12/23/2024
Decision Date 06/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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