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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 K120518
Device Name END TIDAL CO2 NASAL CANNULA
Applicant
CAREFUSION
1500 WAUKEGAN ROAD
WAUKEGAN,  IL  60085
Applicant Contact ERIKA FERNANDEZ
Correspondent
CAREFUSION
1500 WAUKEGAN ROAD
WAUKEGAN,  IL  60085
Correspondent Contact ERIKA FERNANDEZ
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/21/2012
Decision Date 05/04/2012
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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