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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 K083456
Device Name NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Applicant Contact JACK COGGAN
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Correspondent Contact JACK COGGAN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received11/21/2008
Decision Date 03/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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