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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Tissue Saturation
510(k) Number K160526
FOIA Releasable 510(k) K160526
Device Name Masimo O3 Regional Oximeter System
Applicant
MASIMO CORPORATION
52 DISCOVERY
IRVINE,  CA  92618
Applicant Contact MARGUERITE THOMLINSON
Correspondent
MASIMO CORPORATION
52 DISCOVERY
IRVINE,  CA  92618
Correspondent Contact MARGUERITE THOMLINSON
Regulation Number870.2700
Classification Product Code
MUD  
Date Received02/25/2016
Decision Date 06/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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