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

    NEXAN SYSTEM, MODEL NX-300

    K Number: K003520 · Decision Dec 13, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    2
    Review Days
    28

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    Basic Information

    Device Name
    NEXAN SYSTEM, MODEL NX-300
    K Number
    K003520
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nexan, Ltd.
    Date Received
    November 15, 2000
    Decision Date
    December 13, 2000
    Product Code
    MWJ
    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
    MWJ Electrocardiograph, Ambulatory (Without Analysis)

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    Other Clearances by Nexan, Ltd.

    K Number Device Name
    K010424 NEXAN SYSTEM, MODEL NX-301