BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000

    K Number: K131085 · Decision Aug 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    126

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    Basic Information

    Device Name
    CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000
    K Number
    K131085
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1140
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mespere Lifesciences, Inc.
    Date Received
    April 18, 2013
    Decision Date
    August 22, 2013
    Product Code
    PFA
    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
    PFA Non-Invasive Central Venous Manometer

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