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

    MED-GENESIS PATIENT LASER EYE SHIELD

    K Number: K934459 · Decision Feb 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    165

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    Basic Information

    Device Name
    MED-GENESIS PATIENT LASER EYE SHIELD
    K Number
    K934459
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.6500
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Med-Genesis, Inc.
    Date Received
    September 10, 1993
    Decision Date
    February 22, 1994
    Product Code
    IWS
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IWS Shield, Eye, Radiological

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