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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 K110594
Device Name GF-210R MULTI-GAS MODULE FOR NOHON KOHDEN BEDSIDE MONITORS
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 Received03/02/2011
Decision Date 10/28/2011
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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