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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 K033296
Device Name MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
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  
Date Received10/14/2003
Decision Date 02/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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