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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 K120657
Device Name MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS
Applicant
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Applicant Contact PATRICIA MILBANK
Correspondent
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Correspondent Contact PATRICIA MILBANK
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/05/2012
Decision Date 09/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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