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510(k) Data Aggregation

    K Number
    K212163
    Device Name
    Coala Heart Monitor
    Manufacturer
    Coala Life AB
    Date Cleared
    2022-04-14

    (276 days)

    Product Code
    DPS, DQC, DQD, DXH
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    Coala Life AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K182040
    Device Name
    Coala Heart Monitor
    Manufacturer
    Coala Life AB
    Date Cleared
    2019-02-08

    (193 days)

    Product Code
    DXH, DOC, DOD, DPS
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    Coala Life AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Coala Heart Monitor is intended to record, store and transfer single-channel electrocardiogram (ECG) rhythms and heart sound. The Coala Heart Monitor also displays ECG rhythms and detects the presence of normal sinus rhythm and atrial fibrillation (when prescribed or used under the care of a physician). The Coala Heart Monitor is intended for use by healthcare professionals and adults with known or suspected heart conditions. Rx ONLY.
    Device Description
    The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.
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