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

    PCI MODEL 2041-A TELEMETRY MONITOR

    K Number: K894340 · Decision Oct 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    9
    Review Days
    80

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    Basic Information

    Device Name
    PCI MODEL 2041-A TELEMETRY MONITOR
    K Number
    K894340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Accucore, Inc.
    Date Received
    July 14, 1989
    Decision Date
    October 2, 1989
    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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