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

    GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS

    K Number: K915154 · Decision May 27, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    111
    Registration Numbers
    112
    Same Product Code
    54
    Applicant Total
    11
    Review Days
    195

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    Basic Information

    Device Name
    GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS
    K Number
    K915154
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2700
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    C.G.H. Medical, Inc.
    Date Received
    November 14, 1991
    Decision Date
    May 27, 1992
    Product Code
    CAN
    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
    CAN Regulator, Pressure, Gas Cylinder

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