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    K Number
    K173448
    Device Name
    CliniCloud Stethoscope
    Manufacturer
    StethoCloud Pty.Ltd (CliniCloud)
    Date Cleared
    2018-01-25

    (80 days)

    Product Code
    DQD, DEV
    Regulation Number
    870.1875
    Why did this record match?
    Applicant Name (Manufacturer) :

    StethoCloud Pty.Ltd (CliniCloud)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CliniCloud Stethoscope is a digital stethoscope intended for periodic recording of lung and heart sounds to a smartphone device, via the CliniCloud app. It is intended to be used for persons of all ages. The device is for medical diagnostic purposes only.
    Device Description
    The CliniCloud stethoscope is a battery powered electronic stethoscope intended for the periodic recording of lung and heart sounds to a smartphone via a CliniCloud micro-USB to 4-pole audio cable. The CliniCloud Stethoscope features no user interface or speaker and must be used in conjunction with the CliniCloud app on a compatible smartphone. It is intended to be used for persons of all ages.
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