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

    COMPUTERIZED PUPIL

    K Number: K920937 · Decision Oct 2, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    30
    Same Product Code
    2
    Applicant Total
    8
    Review Days
    218

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    Basic Information

    Device Name
    COMPUTERIZED PUPIL
    K Number
    K920937
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1700
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Trek Medical Products, Inc.
    Date Received
    February 27, 1992
    Decision Date
    October 2, 1992
    Product Code
    HLG
    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
    HLG Pupillometer, Ac-Powered

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