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

    MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM

    K Number: K970347 · Decision Aug 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    64
    Applicant Total
    14
    Review Days
    214

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    Basic Information

    Device Name
    MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
    K Number
    K970347
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3600
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paladin Medical, Inc.
    Date Received
    January 27, 1997
    Decision Date
    August 29, 1997
    Product Code
    DTE
    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
    DTE Pulse-Generator, Pacemaker, External

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