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

    ISOVOL-EXCHANGE TRAY

    K Number: K852167 · Decision Nov 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    29
    Applicant Total
    9
    Review Days
    182

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    Basic Information

    Device Name
    ISOVOL-EXCHANGE TRAY
    K Number
    K852167
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Rocky Mountain Medical Corp.
    Date Received
    May 20, 1985
    Decision Date
    November 18, 1985
    Product Code
    BRZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BRZ Set, Blood Transfusion

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    K832298 BABY LIGHT DOSIMETER
    K837494 BABY LIGHT METER