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FDA 510(k)

Breathe Easy Mobile Respiratory Monitor (MRM)

K-Number: K211387 · 2021-11-23

ApplicantSound Life Sciences, Inc.
Decision Date2021-11-23
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Breathe Easy Mobile Respiratory Monitor (MRM) is the device name listed in this FDA 510(k) record. The listed applicant is Sound Life Sciences, Inc.. It received FDA 510(k) clearance on 2021-11-23 under 510(k) number K211387. 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 Breathe Easy Mobile Respiratory Monitor (MRM)?

Breathe Easy Mobile Respiratory Monitor (MRM) is a medical device that received FDA 510(k) clearance on 2021-11-23. The listed applicant is Sound Life Sciences, Inc.. The 510(k) number is K211387.

When did Breathe Easy Mobile Respiratory Monitor (MRM) receive FDA 510(k) clearance?

Breathe Easy Mobile Respiratory Monitor (MRM) received FDA 510(k) clearance on 2021-11-23, under 510(k) number K211387.

Who is the listed applicant for Breathe Easy Mobile Respiratory Monitor (MRM)?

The FDA 510(k) record lists Sound Life Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM)?

The FDA product code for Breathe Easy Mobile Respiratory Monitor (MRM) 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.

NCT02962557Detecting Post-surgical Respiratory Compromise and Prompting Patients to Self-rescue: An Early Feasibility StudyACTIVE_NOT_RECRUITINGNCT07650539Respiratory OBservation Using Ultra-Sensitive nanoTechnologyNOT_YET_RECRUITINGNCT07676227Pulse Oximetry Performance Test for PaMo - Controlled Desaturation TestCOMPLETED

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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