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

    APTEK ULTRASOUND PROCEDURE TRAY

    K Number: K802666 · Decision Nov 26, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    APTEK ULTRASOUND PROCEDURE TRAY
    K Number
    K802666
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    884.1550
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Aptek , Ltd.
    Date Received
    October 28, 1980
    Decision Date
    November 26, 1980
    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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    Other Clearances by Aptek , Ltd.

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