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

    QTMICRO(TM) SYSTEM

    K Number: K950305 · Decision Oct 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    176
    Registration Numbers
    176
    Same Product Code
    200
    Applicant Total
    2
    Review Days
    261

    Basic Information

    Device Name
    QTMICRO(TM) SYSTEM
    K Number
    K950305
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Q.I. MEDICAL, INC.
    Date Received
    January 25, 1995
    Decision Date
    October 13, 1995
    Product Code
    LHI
    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
    LHI Set, I.V. Fluid Transfer

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