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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 K040259
Device Name MASIMO SET INTELLIVUE PULSE OXIMETER MODULE
Applicant
MASIMO CORP.
2852 KELVIN AVE.
IRVINE,  CA  92614 -5826
Applicant Contact JAMES J CRONIN
Correspondent
MASIMO CORP.
2852 KELVIN AVE.
IRVINE,  CA  92614 -5826
Correspondent Contact JAMES J CRONIN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received02/04/2004
Decision Date 04/22/2004
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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