BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    FLEXI-THERM FILM

    K Number: K770986 · Decision Sep 12, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    6
    Applicant Total
    56
    Review Days
    104

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    Basic Information

    Device Name
    FLEXI-THERM FILM
    K Number
    K770986
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    884.2982
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    E-Z-Em, Inc.
    Date Received
    May 31, 1977
    Decision Date
    September 12, 1977
    Product Code
    KXZ
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXZ System, Thermographic, Liquid Crystal, Powered (Adjunctive Use)

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