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

    PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM

    K Number: K982090 · Decision Jan 26, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    9
    Review Days
    225

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    Basic Information

    Device Name
    PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM
    K Number
    K982090
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paceart, Inc.
    Date Received
    June 15, 1998
    Decision Date
    January 26, 1999
    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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    K880283 PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS
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