BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    TEMPUS PRO WITH ENHANCED FEATURES

    K Number: K133973 · Decision Aug 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    1
    Applicant Total
    11
    Review Days
    231

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    Basic Information

    Device Name
    TEMPUS PRO WITH ENHANCED FEATURES
    K Number
    K133973
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    870.1025
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Remote Diagnostic Technologies , Ltd.
    Date Received
    December 26, 2013
    Decision Date
    August 14, 2014
    Product Code
    QYW
    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
    QYW Hospital Cardiac Telemetry

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    Other Clearances by Remote Diagnostic Technologies , Ltd.

    K Number Device Name
    K173768 Tempus Pro Patient Monitor
    K170567 Tempus Pro Patient Monitor
    K134014 TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
    K133988 TEMPUS PRO EXTENDED FEATURES
    K130773 TEMPUS PRO PATIENT MONITOR
    K113105 TEMPUSIC PATIENT MONITOR
    K101264 TEMPUS IC PROFESSIONAL PATIENT MONITOR
    K082718 TEMPUSIC PATIENT MONITOR
    K033410 TEMPUS 2000 PATIENT MONITOR, MODEL 00-0002
    K010436 TEMPUS 2000 PATIENT MONITOR, MODEL 00-0001; TEMPUS MONITORING STATION, MODEL 01-0011
    Search all 11 clearances from Remote Diagnostic Technologies , Ltd. →