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

    ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY

    K Number: K890463 · Decision Apr 7, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    19
    Applicant Total
    1
    Review Days
    67

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    Basic Information

    Device Name
    ULTRASOUND PROCEDURE TRAY AMNICENTESIS TRAY
    K Number
    K890463
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.1550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Applicant
    Critical Specialties, Inc.
    Date Received
    January 30, 1989
    Decision Date
    April 7, 1989
    Product Code
    HIO
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HIO Sampler, Amniotic Fluid (Amniocentesis Tray)

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