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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 K113596
Device Name MASIMO SET REUSABLE OXIMETRY SENSORS
Applicant
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Applicant Contact DAVID COLLETTE
Correspondent
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Correspondent Contact DAVID COLLETTE
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/05/2011
Decision Date 02/24/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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