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

    TOTALCARE

    K Number: K962942 · Decision Feb 3, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    69
    Applicant Total
    33
    Review Days
    189

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    Basic Information

    Device Name
    TOTALCARE
    K Number
    K962942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5100
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill-Rom, Inc.
    Date Received
    July 29, 1996
    Decision Date
    February 3, 1997
    Product Code
    FNL
    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
    FNL Bed, Ac-Powered Adjustable Hospital

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