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

    SHOWER MINI RD-7 SANITARY WASHER

    K Number: K911551 · Decision Sep 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    72
    Applicant Total
    1
    Review Days
    151

    Basic Information

    Device Name
    SHOWER MINI RD-7 SANITARY WASHER
    K Number
    K911551
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    AIEX USA LTD.
    Date Received
    April 8, 1991
    Decision Date
    September 6, 1991
    Product Code
    ILJ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ILJ Bath, Hydro-Massage

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