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510(k) Data Aggregation

    K Number
    K965065
    Device Name
    TECA. MILLENNIUM
    Manufacturer
    MEDELEC LTD.
    Date Cleared
    1997-06-20

    (184 days)

    Product Code
    GWF, GWE, GWJ, IKN, JXE
    Regulation Number
    882.1870
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELEC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Millennium is a 2 or 5 channel electromyograph which provides facilities for ENG and Evoked Potentials testing for a range of clinical applications. Millennium is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment.
    Device Description
    The Millennium is a 2 or 5 channel electromyograph which provides facilities for ENG and Evoked Potentials testing for a range of clinical applications.
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    K Number
    K964280
    Device Name
    DG NERVUS
    Manufacturer
    MEDELEC LTD.
    Date Cleared
    1997-01-27

    (91 days)

    Product Code
    GWQ
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELEC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954157
    Device Name
    DG PORTABLE SYSTEM
    Manufacturer
    MEDELEC LTD.
    Date Cleared
    1996-01-17

    (134 days)

    Product Code
    OLT, GWQ, OLV
    Regulation Number
    882.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDELEC LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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