Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Masimo Acoustic Respiration Sensors, infant and neonate

K-Number: K173976 · 2018-09-05

ApplicantMasimo Corporation
Decision Date2018-09-05
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Masimo Acoustic Respiration Sensors, infant and neonate is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2018-09-05 under approval number K173976. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Masimo Acoustic Respiration Sensors, infant and neonate?

Masimo Acoustic Respiration Sensors, infant and neonate is a medical device that received FDA 510(k) clearance on 2018-09-05. It is manufactured by Masimo Corporation. The 510(k) number is K173976.

When was Masimo Acoustic Respiration Sensors, infant and neonate approved by the FDA?

Masimo Acoustic Respiration Sensors, infant and neonate received FDA 510(k) clearance on 2018-09-05, under approval number K173976.

What company makes Masimo Acoustic Respiration Sensors, infant and neonate?

Masimo Acoustic Respiration Sensors, infant and neonate is manufactured by Masimo Corporation.

What is the FDA product code for Masimo Acoustic Respiration Sensors, infant and neonate?

The FDA product code for Masimo Acoustic Respiration Sensors, infant and neonate is BZQ.

Related Clinical Trials

NCT06432881 Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE) RECRUITING NCT07552025 Detection of Respiratory Events Using Acoustic Monitoring in Extremely Preterm Infants NOT_YET_RECRUITING NCT07556939 Light Utilization COX-Inhibitory Device Therapy for Infant Cardiac Arrest (LUTICA Study). The LUCID Device is Used in the Treatment of Ischemic Brain Reperfusion Injury Caused by Cardiac Arrest in Pediatric Patients. NOT_YET_RECRUITING NCT06148623 Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin Pigmentation COMPLETED

Other Devices by Masimo Corporation

K162675Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter K160940Masimo Disposable Transflectance Forehead Sensor K153225Masimo Root Monitoring System and Accessories K160526Masimo O3 Regional Oximeter System K151644Masimo Root Vital Signs Monitoring System and Accessories K171121Masimo Root Monitoring System and Accessories

View all 41 devices →

Related Devices (Code: BZQ)

K152911EarlySense Insight SytemEarlysense, Ltd. K151940Thora-3Di, Model T-01Pneumacare Limited K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor ActivationHill-Rom, Inc. K171836EarlySense Bed Sensing UnitEarlysense, Ltd. K190775The RHEA Vital Sign Vigilance SystemShenzhen Fiber Medical Technology Co. , Ltd. K200445The C100 Contactless Breathing MonitorCircadia Technologies, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑