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

    MODEL 5866-9M & MODEL 6981M

    K Number: K911827 · Decision Jul 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    102
    Applicant Total
    4
    Review Days
    90

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    Basic Information

    Device Name
    MODEL 5866-9M & MODEL 6981M
    K Number
    K911827
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3620
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Metronic, Inc.
    Date Received
    April 24, 1991
    Decision Date
    July 23, 1991
    Product Code
    DTD
    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
    DTD Pacemaker Lead Adaptor

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    Other Clearances by Metronic, Inc.

    K Number Device Name
    K031210 MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
    K874884 MEDTRONIC(R) ORTHOFLEX(TM)
    K832505 IMAGE PROCESSING SYS A3