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

    WEP 7604 TELEMETRY MONITOR

    K Number: K854369 · Decision Feb 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    166
    Review Days
    122

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    Basic Information

    Device Name
    WEP 7604 TELEMETRY MONITOR
    K Number
    K854369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Nihon Kohden America, Inc.
    Date Received
    October 29, 1985
    Decision Date
    February 28, 1986
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

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