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

    ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.

    K Number: K872265 · Decision Jan 4, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    207

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    Basic Information

    Device Name
    ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.
    K Number
    K872265
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2960
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Labsonics, Inc.
    Date Received
    June 11, 1987
    Decision Date
    January 4, 1988
    Product Code
    HGL
    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
    HGL Transducer, Ultrasonic, Obstetric

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