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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 K033998
FOIA Releasable 510(k) K033998
Device Name MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
Applicant
Masimo Corp.
2852 Kelvin Ave.
Irvine,  CA  92614
Applicant Contact JAMES J CRONIN
Correspondent
Masimo Corp.
2852 Kelvin Ave.
Irvine,  CA  92614
Correspondent Contact JAMES J CRONIN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received12/24/2003
Decision Date 03/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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