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

    FEMTEST

    K Number: K844173 · Decision Aug 14, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    293

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    Basic Information

    Device Name
    FEMTEST
    K Number
    K844173
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1300
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Bionexus, Inc.
    Date Received
    October 25, 1984
    Decision Date
    August 14, 1985
    Product Code
    HES
    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
    HES Insufflator, Carbon-Dioxide, Uterotubal (And Accessories)

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    Other Clearances by Bionexus, Inc.

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