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510(k) Data Aggregation

    K Number
    K993202
    Device Name
    EIM-107 PREP-CHECK
    Manufacturer
    GENERAL DEVICES
    Date Cleared
    1999-12-17

    (84 days)

    Product Code
    GZO,IKJ
    Regulation Number
    882.1540
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EIM-107 PREP-CHECK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EIM-107 is indicated for use whenever it is desired to measure or assess the impedance and/or offset voltage of surface biopotential electrodes applied to the skin of a patient.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the EIM-107 Prep-Check Electrode Impedance Meter. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices. It lists the trade name, regulatory class, product code, and indications for use. It also outlines regulatory responsibilities for the manufacturer.

    Therefore, I cannot provide the requested information based on the input document. The document simply states the FDA's decision regarding market clearance, not the underlying performance data or studies.

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