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

    DRG DISPOSABLE VAGINAL SPECULUM

    K Number: K012535 · Decision Mar 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    122
    Registration Numbers
    122
    Same Product Code
    70
    Applicant Total
    13
    Review Days
    206

    Basic Information

    Device Name
    DRG DISPOSABLE VAGINAL SPECULUM
    K Number
    K012535
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DOCTOR'S RESEARCH GROUP, INC.
    Date Received
    August 7, 2001
    Decision Date
    March 1, 2002
    Product Code
    HIB
    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
    HIB Speculum, Vaginal, Nonmetal

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