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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
Applicant
MASIMO CORPORATION
40 parker
irvine,  CA  92618
Applicant Contact marquerite thomlinson
Correspondent
MASIMO CORPORATION
40 parker
irvine,  CA  92618
Correspodent 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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