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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 K063140
Device Name RAINBOW ADHESIVE CO-OXIMETRY SENSORS
Applicant
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Applicant Contact JAMES J CRONIN
Correspondent
MASIMO CORPORATION
40 PARKER
IRVINE,  CA  92618
Correspondent Contact JAMES J CRONIN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
JKS  
Date Received10/16/2006
Decision Date 12/29/2006
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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