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510(k) Data Aggregation

    K Number
    K991199
    Device Name
    BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150
    Manufacturer
    BIOMED PRODUCTS
    Date Cleared
    1999-06-22

    (75 days)

    Product Code
    GXY,AND,BWY,IKA
    Regulation Number
    882.1320
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOPOTENTIAL SKIN ELECTRODE, MODELS BME 300, BME 200, BME 100, BME 150

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

    BioMed Products biopotential skin electrode will be used by the Bio Medical Community for the acquisition of all surface biopotentials, i.e. Electroencephalographs (EEG), Electromyographs (EMG), and Electrooculographs (EOG).

    Device Description

    Biopotential Skin Electrode

    AI/ML Overview

    The provided document is a 510(k) clearance letter for a medical device (Biopotential Skin Electrode). It does not contain any information regarding acceptance criteria related to device performance or a study proving its conformance to such criteria.

    The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, not a demonstration of specific performance metrics against pre-defined acceptance criteria.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study proving the device meets them based on the provided text. The document is administrative in nature, detailing regulatory clearance, and does not include scientific study results or performance data.

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