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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name oximeter
510(k) Number K121912
Device Name E1 EAR SENSORS
Original Applicant
MASIMO CORPORATION
40 parker
irvine,  CA  92618
Original Contact david collette
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/02/2012
Decision Date 07/24/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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