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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMED PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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