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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
Models 2802M-10,2802F-10, 2812M-10,2812F-10, 281M-10,2811F-10, 28M2F, 28M2M
Device Name END TIDAL CO2 NASAL CANNULA
Original Applicant
CAREFUSION
1500 waukegan road
waukegan,  IL  60085
Original Contact erika fernandez
Regulation Number868.1400
Classification Product Code
CCK  
Date Received02/21/2012
Decision Date 05/04/2012
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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