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

    PERITONE

    K Number: K800191 · Decision Apr 16, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    63
    Applicant Total
    2
    Review Days
    78

    Basic Information

    Device Name
    PERITONE
    K Number
    K800191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1425
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    LAURIE ANN KAISER, PH.D.
    Date Received
    January 29, 1980
    Decision Date
    April 16, 1980
    Product Code
    HIR
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HIR Perineometer

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    Other Clearances by LAURIE ANN KAISER, PH.D.

    K Number Device Name
    K860552 PERITONE DISPOSAL SHEATH - RUBBER AND VINYL