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

    PACEVIEW

    K Number: K895535 · Decision Mar 19, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    187

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    Basic Information

    Device Name
    PACEVIEW
    K Number
    K895535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3640
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Micromedical
    Date Received
    September 13, 1989
    Decision Date
    March 19, 1990
    Product Code
    KRE
    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
    KRE Analyzer, Pacemaker Generator Function, Indirect

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    Other Clearances by Micromedical

    K Number Device Name
    K895534 BIOLOG