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

    ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER

    K Number: K905000 · Decision Jan 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    29
    Applicant Total
    5
    Review Days
    85

    Basic Information

    Device Name
    ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
    K Number
    K905000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2225
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    COROMETRICS MEDICAL SYSTEMS, INC.
    Date Received
    November 7, 1990
    Decision Date
    January 31, 1991
    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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