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510(k) Data Aggregation

    K Number
    K983550
    Device Name
    XYZ SYSTEM
    Date Cleared
    1999-01-07

    (90 days)

    Product Code
    Regulation Number
    882.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIO-MONITORING INTERNATIONAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The XYZ System is intended for biofeedback for relaxation and re-education of muscles.
    Device Description
    The XYZ System contains 5 major parts. The Analog to Digital Housing with Isolation Ampitifiers and Isolated Power, the Analog to Digital Housing with Issac De Amplifiers an Housing with Isolathon Ampilliers and Toulater Converter, the IBM-PC compatible computer and XYZ Software.
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