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510(k) Data Aggregation

    K Number
    K021087
    Device Name
    HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE
    Manufacturer
    ERECORDS LIMITED
    Date Cleared
    2002-10-11

    (191 days)

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

    ERECORDS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hippocrat is an electronically amplified device intended for use in projecting the sounds associated with the heart and other internal organs. The Hippocrat records, stores, plays back, and electronically transmits these sounds.
    Device Description
    The Hippocrat Electronic Stethoscope is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, stores, plays back, and transmits sounds associated with the heart, arteries, and veins and other internal organs. Significant components include a control unit, installation software; and power supply/charger. The user must supply a personal computer with a Microsoft Windows 98, NT 4.0, 2000, or XP operating system, CD-ROM drive, and Infrared Port. The stored sounds can be transmitted via e-mail.
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