BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ACTIVE ELECTRODE MONITORING SYSTEM

    K Number: K000480 · Decision May 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    6
    Review Days
    78

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    Basic Information

    Device Name
    ACTIVE ELECTRODE MONITORING SYSTEM
    K Number
    K000480
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Electroscope, Inc.
    Date Received
    February 14, 2000
    Decision Date
    May 2, 2000
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Electroscope, Inc.

    K Number Device Name
    K972562 BIPOLAR ELECTROSURGICAL PENCIL, STRAIGHT AND ANGLED
    K973682 BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT, BIOPOLAR ARTHROSCOPIC PROBE, ANGLED, BIPOLAR ARTHROSCOPIC PROBE, STRAIGHT,
    K912780 MONOPOLAR LAPAROSCOPIC ELECTRODES W/ELETROSHIELD
    K912781 ELECTROSHIELD
    K913625 ELECTROSCOPE MONITOR, EM-1