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510(k) Data Aggregation

    K Number
    K050248
    Device Name
    ELECTRODE
    Manufacturer
    ELECTRAMOLD
    Date Cleared
    2005-05-25

    (111 days)

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

    ELECTRAMOLD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ECG electrode is intended to monitor patients. The electrode monitors and relates body functions through a monitoring device. The electrode senses functions in the body, gathers information, and relates that information to the device with which it is connected. The information gathered by the electrode can then be assessed by medical personnel in order to aid in determining the proper medical course of action.
    Device Description
    Not Found
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