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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 K161860
Device Name TG-970P CO2 Sensor Kit
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 PARKWAY
IRVINE,  CA  92618
Correspondent Contact THOMAS BENTO
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/06/2016
Decision Date 02/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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