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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 K080238
Device Name MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER
Original Applicant
MASIMO CORPORATION
40 parker
irvine,  CA  92618
Original Contact marquerite thomlinson
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
DPZ   JKS  
Date Received01/31/2008
Decision Date 05/12/2008
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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