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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-monoxide, gaseous-phase
510(k) Number K121768
Model C20110
Device Name COSENSE
Original Applicant
2445 faber place, stuite 250
palo alto,  CA  94303
Original Contact julie blacklock
Regulation Number868.1430
Classification Product Code
Date Received06/15/2012
Decision Date 10/31/2012
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