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

    LiDCOunity Monitor

    K Number: K152935 · Decision Mar 17, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    7
    Review Days
    164

    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
    LiDCOunity Monitor
    K Number
    K152935
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1435
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lidco, Ltd.
    Date Received
    October 5, 2015
    Decision Date
    March 17, 2016
    Product Code
    DXG
    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
    DXG Computer, Diagnostic, Pre-Programmed, Single-Function

    Similar 510(k) Clearances

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

    Argos Infinity (Rev. 1.0)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalStream ART Connect; VitalStream-Hemo

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Cogent™ Hemodynamic Monitoring System; Cogent™ HMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hypotension Decision Assist Model HDA-OR2

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PulsioFlex Monitoring System with ProAQT Sensor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EV1000 Clinical Platform

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

    Other Clearances by Lidco, Ltd.

    K Number Device Name
    K163334 LiDCOunity v2 Hemodynamic Monitor
    K131048 LIDCO CNAP MODULE
    K122247 LIDCORAPID V2 MONITOR
    K023960 LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
    K010049 PULSECO HEMODYNAMIC MONITOR CM71
    K962918 LIDCO SYSTEM