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

    TOITU DOPPLER FETUS DETECTOR, FD-400D

    K Number: K890139 · Decision Mar 29, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    59
    Applicant Total
    2
    Review Days
    75

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    Basic Information

    Device Name
    TOITU DOPPLER FETUS DETECTOR, FD-400D
    K Number
    K890139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Toitu of America, Inc.
    Date Received
    January 13, 1989
    Decision Date
    March 29, 1989
    Product Code
    KNG
    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
    KNG Monitor, Ultrasonic, Fetal

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    Other Clearances by Toitu of America, Inc.

    K Number Device Name
    K894036 TOITU FETAL ACTOCARDIOGRAPH, MT-332