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

    Central Venous Pressure System

    K Number: K151776 · Decision Aug 12, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    42

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    Basic Information

    Device Name
    Central Venous Pressure System
    K Number
    K151776
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1140
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mespere Lifesciences, Inc.
    Date Received
    July 1, 2015
    Decision Date
    August 12, 2015
    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

    Similar 510(k) Clearances

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

    CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000

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

    Other Clearances by Mespere Lifesciences, Inc.

    K Number Device Name
    K182242 VO200 – NeurOs Cerebral Oximetry System
    K131085 CENTRAL VENOUS PRESSURE SYSTEM - MESPERE VENUS 1000