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

    PACEART TX3 CARDIAC EVENT RECORDER

    K Number: K012407 · Decision Aug 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    9
    Review Days
    15

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    Basic Information

    Device Name
    PACEART TX3 CARDIAC EVENT RECORDER
    K Number
    K012407
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paceart, Inc.
    Date Received
    July 30, 2001
    Decision Date
    August 14, 2001
    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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    Other Clearances by Paceart, Inc.

    K Number Device Name
    K982090 PACEART HOME TRAK PLUS EASI EVENT RECORDER SYSTEM
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    K960721 PACEART WRIST ELECTRODES
    K952065 PACEART CARDIOVOICE
    K931296 PACEART CARDIOPHONE
    K915632 PACEART CPTS-86/12
    K880283 PACEART PACEMAKER PATIENT TEST SYST/TEL OPT CPTS
    K870909 PACEMAKER FUNCTION ANALYZER