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510(k) K173976

Masimo Acoustic Respiration Sensors, infant and neonate by Masimo Corporation — Product Code BZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2018
Date Received
December 29, 2017
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Breathing Frequency
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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