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

    SHOWER TROLLEY

    K Number: K841395 · Decision May 7, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    206
    Registration Numbers
    207
    Same Product Code
    12
    Applicant Total
    7
    Review Days
    34

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    Basic Information

    Device Name
    SHOWER TROLLEY
    K Number
    K841395
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5510
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Setma, Inc.
    Date Received
    April 3, 1984
    Decision Date
    May 7, 1984
    Product Code
    FSA
    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
    FSA Lift, Patient, Non-Ac-Powered

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