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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 K041815
Device Name LNCS OXIMETRY SENSORS
Applicant
MASIMO CORP.
40 PARKER
IRVINE,  CA  92618
Applicant Contact JAMES J CRONIN
Correspondent
MASIMO CORP.
40 PARKER
IRVINE,  CA  92618
Correspondent Contact JAMES J CRONIN
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/06/2004
Decision Date 07/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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