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

    DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM

    K Number: K003916 · Decision Apr 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    482

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    Basic Information

    Device Name
    DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
    K Number
    K003916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5250
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Scandia Manufacturing , Ltd.
    Date Received
    December 19, 2000
    Decision Date
    April 15, 2002
    Product Code
    IMB
    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
    IMB Cabinet, Moist Steam

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