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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 K251641
Device Name GF-310R Multigas Unit (GF-310R)
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo,  JP 161-8560
Applicant Contact Charlemagne Chua
Correspondent
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo,  JP 161-8560
Correspondent Contact Charlemagne Chua
Regulation Number868.1400
Classification Product Code
CCK  
Date Received05/29/2025
Decision Date 08/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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