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510(k) Data Aggregation

    K Number
    K062364
    Device Name
    I-SCOPE 200
    Date Cleared
    2006-12-06

    (114 days)

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

    DONGJIN MEDICAL CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The i-Scope 200 is intended for medical diagnostic purposes only. It can be used for the amplification of heart, lung and other body sounds with the use of selective frequency and can be used on any patient undergoing a physical assessment.
    Device Description
    i-scope 200 digital stethoscope is a new advanced product compared to conventional stethoscopes that removes noise from tube of standard stethoscope. It dose not cause pain to the ear despite long-term use due to newly introduced soft materials applied in earphone. i-scope 200 digital stethoscope is intended for medical diagnostic purposes only. It is used for the amplification of heart, lung and other body sounds with selective frequency filtering. This product is not designed, sold, or intended for any other use.
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