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

    MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE

    K Number: K911901 · Decision Jul 26, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    31
    Applicant Total
    1
    Review Days
    88

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    Basic Information

    Device Name
    MAXI CABINET OPTIONAL BUILT IN S6000 LIGHT SOURCE
    K Number
    K911901
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.5300
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Stortz
    Date Received
    April 29, 1991
    Decision Date
    July 26, 1991
    Product Code
    ETF
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETF Unit, Examining/Treatment, Ent

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