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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 the device name listed in this FDA 510(k) record. The listed applicant is Masimo Corporation. It received FDA 510(k) clearance on 2018-09-05 under 510(k) 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. The listed applicant is Masimo Corporation. The 510(k) number is K173976.

When did Masimo Acoustic Respiration Sensors, infant and neonate receive FDA 510(k) clearance?

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

Who is the listed applicant for Masimo Acoustic Respiration Sensors, infant and neonate?

The FDA 510(k) record lists Masimo Corporation as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07223177Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric PopulationsRECRUITINGNCT06432881Investigation of Skin Pigmentation Effect on Performance of Masimo Pulse Oximetry (INSPIRE)COMPLETEDNCT06148623Clinical Performance Testing of Philips FAST SpO2 With Masimo Pulse Oximetry Sensors Across Skin PigmentationCOMPLETEDNCT02986789Continuous Non-Invasive SpHb and PVI Monitoring on Intra-Operative and Post-Surgical Clinical OutcomesTERMINATEDNCT03706430Validation of RPVi as a Parameter to Predict Fluid ResponsivenessTERMINATEDNCT06289556Clinical Performance of Masimo INVSENSOR00048TERMINATED

Other records listing Masimo Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: BZQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253274BedDot (G1)Intelligent Dots, LLCK251326Respiration Rate algorithmEdwards Lifesciences, LLCK250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)Linshom Medical, Inc.K250934Respiree Cardio- Respiratory Monitor SystemRespiree Pte, Ltd.K243183RTMsense Respiratory Monitoring SystemRtm Vital Signs, LLCK243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)Faceheart Corp.

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.

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