BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM

    K Number: K031555 · Decision Jul 8, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    14
    Applicant Total
    402
    Review Days
    50

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    Basic Information

    Device Name
    SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
    K Number
    K031555
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes (Usa)
    Date Received
    May 19, 2003
    Decision Date
    July 8, 2003
    Product Code
    LXC
    Advisory Committee
    Unknown
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LXC Monitor, Pressure, Intracompartmental

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