BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent - Subject to Tracking Reg. 🇺🇸 United States

    AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)

    K Number: K954714 · Decision Feb 1, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    486
    Applicant Total
    8
    Review Days
    122

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    Basic Information

    Device Name
    AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION)
    K Number
    K954714
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    870.3680
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent - Subject to Tracking Reg.
    Applicant
    Pacesetter, Inc.
    Date Received
    October 2, 1995
    Decision Date
    February 1, 1996
    Product Code
    DTB
    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
    DTB Permanent Pacemaker Electrode

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