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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 K082052
Device Name MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK
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  
Date Received07/21/2008
Decision Date 10/10/2008
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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