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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 K092838
Device Name MASIMO SET RAD 8 PULSE OXIMETER AND ACCESSORIES, MODEL RAD 8
Applicant
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Applicant Contact MARGUERITE THOMLINSON
Correspondent
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Correspondent Contact MARGUERITE THOMLINSON
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received09/15/2009
Decision Date 10/15/2009
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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