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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 K122214
Model TG-970P
Device Name TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
Original Applicant
NIHON KOHDEN CORP.
90 icon street
foothill ranch,  CA  92610
Original Contact steve geerdes
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/25/2012
Decision Date 05/21/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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