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

    MULTI-LINK CABLE AND LEAD WIRE SYSTEMS

    K Number: K980582 · Decision Mar 16, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    104
    Applicant Total
    9
    Review Days
    27

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    Basic Information

    Device Name
    MULTI-LINK CABLE AND LEAD WIRE SYSTEMS
    K Number
    K980582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Marquette Medical Systems, Inc.
    Date Received
    February 17, 1998
    Decision Date
    March 16, 1998
    Product Code
    DSA
    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
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

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