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

    ORCEPAD

    K Number: K875123 · Decision Jun 21, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    189

    Basic Information

    Device Name
    ORCEPAD
    K Number
    K875123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4900
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    ALTON DEAN MEDICAL, INC.
    Date Received
    December 15, 1987
    Decision Date
    June 21, 1988
    Product Code
    HDD
    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
    HDD Table, Obstetrical, Ac-Powered (And Accessories)

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