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510(k) Data Aggregation

    K Number
    K993623
    Device Name
    GEMINI E
    Date Cleared
    2000-06-23

    (241 days)

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

    ALLEN MEDICAL INSTRUMENTS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    1) Normal auscultation of the cardiovascular system, pulmonary system or gastro-intestinal system by a health care professional. 2) Normal auscultation as above by a health care professional who wears hearing aids. 3) To allow four other listeners (e.g. students) to listen together with a health care professional.
    Device Description
    An electronic stethoscope utilizing conventional stethoscope components but amplifying auscultated sounds by means of a 3 volt electronic circuit. An output jack is provided for headphone use. The stethoscope is controlled by a single button which turns the unit on and adjusts the amplitude through four levels.
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