BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR

    K Number: K914776 · Decision Dec 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    10
    Applicant Total
    6
    Review Days
    57

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    Basic Information

    Device Name
    OXFORD PRESSURE MONITOR/TALLEY PRESSURE MONITOR
    K Number
    K914776
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.1600
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Talley Group, Ltd.
    Date Received
    October 23, 1991
    Decision Date
    December 19, 1991
    Product Code
    JFC
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JFC System, Pressure Measurement, Intermittent

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