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

    QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM

    K Number: K894992 · Decision Feb 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    199

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    Basic Information

    Device Name
    QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM
    K Number
    K894992
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Quantum Medical Systems, Inc.
    Date Received
    August 8, 1989
    Decision Date
    February 23, 1990
    Product Code
    MAA
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MAA Monitor, Fetal Doppler Ultrasound

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    Other Clearances by Quantum Medical Systems, Inc.

    K Number Device Name
    K904019 QUANTUM 2000 ANGIODYNOGRAPH ULTRASOUND SYSTEM
    K890998 QAD ANGIODYNOGRAPH ULTRASOUND: COLOR DOPPLER EVAL.
    K860581 QAD-1 ANGIODYNOGRAPH ULTRASOUND SYSTEM
    K853217 QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES