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

    ULTRASONIC IMAGER

    K Number: K780876 · Decision Jun 27, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    29
    Applicant Total
    33
    Review Days
    28

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    Basic Information

    Device Name
    ULTRASONIC IMAGER
    K Number
    K780876
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2225
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Air-Shields, Inc.
    Date Received
    May 30, 1978
    Decision Date
    June 27, 1978
    Product Code
    HEM
    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
    HEM Imager, Ultrasonic Obstetric-Gynecologic

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