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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 K160940
Device Name Masimo Disposable Transflectance Forehead Sensor
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
DQA  
Date Received04/04/2016
Decision Date 11/23/2016
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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