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

    SONICAID MODEL VASOFLO 4

    K Number: K895909 · Decision Jul 9, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    8
    Applicant Total
    48
    Review Days
    272

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    Basic Information

    Device Name
    SONICAID MODEL VASOFLO 4
    K Number
    K895909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Oxford Medilog, Inc.
    Date Received
    October 10, 1989
    Decision Date
    July 9, 1990
    Product Code
    MAA
    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
    MAA Monitor, Fetal Doppler Ultrasound

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