BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    KHURI REGIONAL TISSUE PH MONITOR

    K Number: K862114 · Decision Jun 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    11
    Review Days
    22

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    Basic Information

    Device Name
    KHURI REGIONAL TISSUE PH MONITOR
    K Number
    K862114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1170
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Vascular Technology Incorporated
    Date Received
    June 3, 1986
    Decision Date
    June 25, 1986
    Product Code
    CBZ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

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