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

    MODIFIED EPICARDIAL ARRAY

    K Number: K902228 · Decision Jul 6, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    86
    Registration Numbers
    86
    Same Product Code
    182
    Applicant Total
    566
    Review Days
    50

    Basic Information

    Device Name
    MODIFIED EPICARDIAL ARRAY
    K Number
    K902228
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1220
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    C.R. BARD, INC.
    Date Received
    May 17, 1990
    Decision Date
    July 6, 1990
    Product Code
    DRF
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

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