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

    DERMGARD SYSTEM 800 AND 900

    K Number: K880486 · Decision Feb 22, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    56
    Applicant Total
    1
    Review Days
    18

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    Basic Information

    Device Name
    DERMGARD SYSTEM 800 AND 900
    K Number
    K880486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5170
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Dermgard, Inc.
    Date Received
    February 4, 1988
    Decision Date
    February 22, 1988
    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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