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

    NEOCATH 1000 W/HEPCOTE

    K Number: K832793 · Decision Sep 26, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    22
    Applicant Total
    12
    Review Days
    38

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    Basic Information

    Device Name
    NEOCATH 1000 W/HEPCOTE
    K Number
    K832793
    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
    August 19, 1983
    Decision Date
    September 26, 1983
    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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