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

    RETINA TESTER

    K Number: K914393 · Decision Mar 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    153

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    Basic Information

    Device Name
    RETINA TESTER
    K Number
    K914393
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1630
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Retina Tester
    Date Received
    October 1, 1991
    Decision Date
    March 2, 1992
    Product Code
    HLX
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HLX Photostimulator, Ac-Powered

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