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510(k) Data Aggregation

    K Number
    K970116
    Device Name
    ESG-1 ELECTROSONOGRAM (ESG-1)
    Manufacturer
    MYO-TRONICS, INC.
    Date Cleared
    1997-04-02

    (79 days)

    Product Code
    NFQ
    Regulation Number
    872.2050
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    Product Code :

    NFQ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELECTROSONOGRAM ESC-I is a non-invasive device that measures and records sounds enitted from the temporomandibular (jaw) joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
    Device Description
    ESG-1 Electrosonogram is a non-invasive device that measures and records sounds emitted from the temporomandibular joint along with the relative position of the jaw as a means of assessing the status of the temporomandibular joint.
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