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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
Device Name TG-970P SENSOR KIT W/ NEW AIRWAY ADAPTER (YG-213T)
Applicant
NIHON KOHDEN CORP.
90 ICON STREET
FOOTHILL RANCH,  CA  92610
Applicant Contact STEVE GEERDES
Correspondent
NIHON KOHDEN CORP.
90 ICON STREET
FOOTHILL RANCH,  CA  92610
Correspondent Contact STEVE GEERDES
Regulation Number868.1400
Classification Product Code
CCK  
Date Received07/25/2012
Decision Date 05/21/2013
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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