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510(k) Data Aggregation

    K Number
    K983597
    Device Name
    NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
    Manufacturer
    MEDICOTEST, INC.
    Date Cleared
    1999-01-11

    (90 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICOTEST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Recording muscle activity for Electromyography (EMG) applications. For single patient use only.
    Device Description
    Neuroline Disposable Monopolar Needle Electrode
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    K Number
    K970639
    Device Name
    NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPE NO: 72000-S, 72010-K
    Manufacturer
    MEDICOTEST, INC.
    Date Cleared
    1997-05-15

    (84 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICOTEST, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961643
    Device Name
    MEDICOTEST ECG ELECTRODES
    Manufacturer
    MEDICOTEST, INC.
    Date Cleared
    1996-12-09

    (224 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICOTEST, INC.

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

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