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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 K121914
Device Name MASIMO SET USPO2 PULSE OXIMETRY CABLE
Applicant
MASIMO CORPORATION
40 parker
irvine,  CA  92618
Contact david collette
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/02/2012
Decision Date 09/07/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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