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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 K110028
Device Name MASIMO RADICAL Y PULSE CO-OXIMETER
Applicant
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Applicant Contact SHELLY HARRIS
Correspondent
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Correspondent Contact SHELLY HARRIS
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
BZQ   DPZ   JKS  
Date Received01/05/2011
Decision Date 03/17/2011
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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