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

    TEMPUS IC PROFESSIONAL PATIENT MONITOR

    K Number: K101264 · Decision May 11, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    11
    Review Days
    6

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    Basic Information

    Device Name
    TEMPUS IC PROFESSIONAL PATIENT MONITOR
    K Number
    K101264
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Remote Diagnostic Technologies , Ltd.
    Date Received
    May 5, 2010
    Decision Date
    May 11, 2010
    Product Code
    MWI
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

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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
    K133973 TEMPUS PRO WITH ENHANCED FEATURES
    K134014 TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)
    K133988 TEMPUS PRO EXTENDED FEATURES
    K130773 TEMPUS PRO PATIENT MONITOR
    K113105 TEMPUSIC 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. →