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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 K171765
Device Name Nihon Kohden CO2 Monitor
Applicant
Nihon Kohden Corporation
1-31-4 Nishiochiai, Shinjuku-Ku
Tokyo,  JP 161-8560
Applicant Contact Thomas Bento
Correspondent
Nihon Kohden America, Inc.
15353 Barranca Pkwy.
Rvine,  CA  92618
Correspondent Contact Thomas Bento
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
MNK  
Date Received06/14/2017
Decision Date 10/11/2017
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
Recalls CDRH Recalls
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