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

    NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100

    K Number: K993643 · Decision Dec 28, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    1
    Review Days
    61

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    Basic Information

    Device Name
    NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
    K Number
    K993643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nexan Telemed , Ltd.
    Date Received
    October 28, 1999
    Decision Date
    December 28, 1999
    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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