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

    I.V. STAT MASTER

    K Number: K852254 · Decision Nov 18, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    424
    Registration Numbers
    424
    Same Product Code
    1173
    Applicant Total
    6
    Review Days
    178

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    Basic Information

    Device Name
    I.V. STAT MASTER
    K Number
    K852254
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    The Master Medical Corp.
    Date Received
    May 24, 1985
    Decision Date
    November 18, 1985
    Product Code
    FPA
    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
    FPA Set, Administration, Intravascular

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    Other Clearances by The Master Medical Corp.

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    K905497 MASTER FLOW I.V. PUMPETTE
    K871753 MASTER MEDICAL DEVICE IS I.V. STAT 2
    K792560 MASTER I.V. DIAL LOCK