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

    FETAL PULSE DETECTOR MODEL DOP-1

    K Number: K902190 · Decision Oct 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    10
    Review Days
    159

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    Basic Information

    Device Name
    FETAL PULSE DETECTOR MODEL DOP-1
    K Number
    K902190
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2660
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Medical Systems, Inc.
    Date Received
    May 16, 1990
    Decision Date
    October 22, 1990
    Product Code
    HEK
    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
    HEK Monitor, Heart Sound, Fetal, Ultrasonic

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