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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
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