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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K173976
Device Name Masimo Acoustic Respiration Sensors, infant and neonate
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Karina Simpson
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Sindura Penubarthi
Regulation Number868.2375
Classification Product Code
BZQ  
Subsequent Product Code
DQA  
Date Received12/29/2017
Decision Date 09/05/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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