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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 K020046
Device Name MULTIGAS UNIT, MODEL AG-920RA
Applicant
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Applicant Contact SERRAH NAMINI
Correspondent
Nihon Kohden America, Inc.
90 Icon St.
Foothill Ranch,  CA  92610 -1601
Correspondent Contact SERRAH NAMINI
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
CBQ   CBR   CBS   CCL   NHO  
NHP   NHQ  
Date Received01/07/2002
Decision Date 07/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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