BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    HEEL GARD

    K Number: K790954 · Decision Jun 20, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    HEEL GARD
    K Number
    K790954
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6140
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Fem-Gard, Inc.
    Date Received
    May 22, 1979
    Decision Date
    June 20, 1979
    Product Code
    FRK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FRK Chair, Examination And Treatment

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