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

    THE BRUNO POWERBASE, MODEL PSB-2200

    K Number: K991954 · Decision Nov 2, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    580
    Applicant Total
    12
    Review Days
    145

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    Basic Information

    Device Name
    THE BRUNO POWERBASE, MODEL PSB-2200
    K Number
    K991954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.3860
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bruno Independent Living Aids, Inc.
    Date Received
    June 10, 1999
    Decision Date
    November 2, 1999
    Product Code
    ITI
    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
    ITI Wheelchair, Powered

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