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

    MODEL U-1000 ULTRASONIC SCANNER

    K Number: K851902 · Decision Sep 27, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    29
    Applicant Total
    68
    Review Days
    150

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    Basic Information

    Device Name
    MODEL U-1000 ULTRASONIC SCANNER
    K Number
    K851902
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2225
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Fukuda Denshi USA, Inc.
    Date Received
    April 30, 1985
    Decision Date
    September 27, 1985
    Product Code
    HEM
    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
    HEM Imager, Ultrasonic Obstetric-Gynecologic

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