BEUDAMED
    Product Code: MLN FDA class 2 21 CFR 870.2360

    Electrode, Electrocardiograph, Multi-Function

    Cardiovascular

    The Multi-Function Electrocardiograph Electrode is an adhesive electrode designed to be applied to the patient's skin during ECG recording and capable of serving multiple functions such as monitoring, pacing, and defibrillation without requiring electrode changes, reducing procedure interruptions in cardiac care settings. Classified as a Class 2 device under 21 CFR 870.2360 within the Cardiovascular specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    0
    FEI Numbers
    20
    Registration Numbers
    20
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MLN
    Device Class
    FDA class 2
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Review Panel
    CV
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.