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

    MODEL 5650 OPTIMATE PERSONAL PROGRAMMER

    K Number: K884522 · Decision Aug 25, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    302

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    Basic Information

    Device Name
    MODEL 5650 OPTIMATE PERSONAL PROGRAMMER
    K Number
    K884522
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3700
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Teletronics, Inc.
    Date Received
    October 27, 1988
    Decision Date
    August 25, 1989
    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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