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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 K120984
Device Name MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR
Applicant
Masimo Corporation
40 Parker
Irvine,  CA  92618
Applicant Contact PATRICIA MILBANK
Correspondent
Masimo Corporation
40 Parker
Irvine,  CA  92618
Correspondent Contact PATRICIA MILBANK
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
BZA  
Date Received04/02/2012
Decision Date 04/26/2013
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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