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

    TEMPUS PRO PATIENT MONITOR

    K Number: K130773 · Decision Jun 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    305
    Applicant Total
    11
    Review Days
    77

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    TEMPUS PRO PATIENT MONITOR
    K Number
    K130773
    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
    March 20, 2013
    Decision Date
    June 5, 2013
    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)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MWI), ordered by most recent decision date.

    Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    c-med0 alpha

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WAVE Clinical Platform (2.0.000)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WARD-CSS (v1.2.x)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    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
    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. →