Masimo Acoustic Respiration Sensors, infant and neonate— 510(k) K173976

Substantially Equivalent

Masimo Corporation

FDA 510(k) clearance K173976 for Masimo Acoustic Respiration Sensors, infant and neonate, Substantially Equivalent on 2018-09-05. Applicant: Masimo Corporation. Device class: 2.

Clearance details

Applicant
Masimo Corporation
Product code
Code BZQ
Device class
Class 2
Regulation
21 CFR 868.2375
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Irvine, CA, US
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