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

    TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2

    K Number: K122473 · Decision Jun 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    56
    Applicant Total
    2
    Review Days
    293

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    Basic Information

    Device Name
    TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2
    K Number
    K122473
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5170
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill-Rom
    Date Received
    August 14, 2012
    Decision Date
    June 3, 2013
    Product Code
    IOQ
    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
    IOQ Bed, Flotation Therapy, Powered

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