BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    PARAGON PORTABLE

    K Number: K945041 · Decision Mar 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    125
    Registration Numbers
    125
    Same Product Code
    101
    Applicant Total
    2
    Review Days
    153

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    Basic Information

    Device Name
    PARAGON PORTABLE
    K Number
    K945041
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5550
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pegabus Egerton, Ltd.
    Date Received
    October 14, 1994
    Decision Date
    March 16, 1995
    Product Code
    FNM
    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
    FNM Mattress, Air Flotation, Alternating Pressure

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