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

    EXTERNAL PACEMAKER WIRE DRESSING CHANGE

    K Number: K881356 · Decision May 19, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    128
    Applicant Total
    2
    Review Days
    52

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    Basic Information

    Device Name
    EXTERNAL PACEMAKER WIRE DRESSING CHANGE
    K Number
    K881356
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Neal & Assoc., Inc.
    Date Received
    March 28, 1988
    Decision Date
    May 19, 1988
    Product Code
    LDF
    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
    LDF Electrode, Pacemaker, Temporary

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    Other Clearances by Neal & Assoc., Inc.

    K Number Device Name
    K925924 NEAL WRIST CONES