BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    CONTINUCATH

    K Number: K860808 · Decision Mar 13, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    22
    Applicant Total
    12
    Review Days
    9

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    Basic Information

    Device Name
    CONTINUCATH
    K Number
    K860808
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1200
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Orange Medical Instruments, Inc.
    Date Received
    March 4, 1986
    Decision Date
    March 13, 1986
    Product Code
    CCE
    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
    CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling

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