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510(k) Data Aggregation

    K Number
    K211387
    Device Name
    Breathe Easy Mobile Respiratory Monitor (MRM)
    Manufacturer
    Sound Life Sciences, Inc.
    Date Cleared
    2021-11-23

    (202 days)

    Product Code
    BZQBZO
    Regulation Number
    868.2375
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sound Life Sciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for the spot measurement of respiration rate of an adult patient in a home or clinical setting. It is not a vital signs monitor or an apnea monitor. It should not be used on patients that exhibit uncontrolled limb movement.
    Device Description
    Not Found
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