BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Soteria Bed Barrier

    K Number: K201876 · Decision Sep 1, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    786

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    Basic Information

    Device Name
    Soteria Bed Barrier
    K Number
    K201876
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6190
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trinity Guardion
    Date Received
    July 7, 2020
    Decision Date
    September 1, 2022
    Product Code
    QTV
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QTV Mattress And Bed Deck Cover (Medical Purposes)