BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004

    K Number: K882429 · Decision Jul 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    24
    Applicant Total
    6
    Review Days
    38

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    Basic Information

    Device Name
    MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004
    K Number
    K882429
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Tpl-Cordis, Inc.
    Date Received
    June 14, 1988
    Decision Date
    July 22, 1988
    Product Code
    KRG
    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
    KRG Programmer, Pacemaker

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