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

    LiDCOunity v2 Hemodynamic Monitor

    K Number: K163334 · Decision Jun 5, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    63
    Registration Numbers
    63
    Same Product Code
    176
    Applicant Total
    7
    Review Days
    189

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    Basic Information

    Device Name
    LiDCOunity v2 Hemodynamic Monitor
    K Number
    K163334
    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
    November 28, 2016
    Decision Date
    June 5, 2017
    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

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    Other Clearances by Lidco, Ltd.

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    K122247 LIDCORAPID V2 MONITOR
    K023960 LIDCOPLUS HEMODYNAMIC MONITOR SYSTEM, MODEL HM 70
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