BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    MEDICAL TREATMENT CHAIR, T400, T500,T600

    K Number: K091727 · Decision Jul 6, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    25

    Basic Information

    Device Name
    MEDICAL TREATMENT CHAIR, T400, T500,T600
    K Number
    K091727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3110
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    FRESENIUS MEDICAL CARE SOUTH ASIA PACIFIC PTY LTD.
    Date Received
    June 11, 2009
    Decision Date
    July 6, 2009
    Product Code
    INO
    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
    INO Chair, Positioning, Electric

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