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

    DERMA HOOD

    K Number: K131338 · Decision Jul 10, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    62

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    Basic Information

    Device Name
    DERMA HOOD
    K Number
    K131338
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6320
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Globalmedia Group, LLC
    Date Received
    May 9, 2013
    Decision Date
    July 10, 2013
    Product Code
    PEQ
    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
    PEQ Accessories To Examination Light