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

    CORNEAL TOPOGRAPHY SYSTEM

    K Number: K923435 · Decision Feb 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    18
    Same Product Code
    28
    Applicant Total
    2
    Review Days
    218

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    Basic Information

    Device Name
    CORNEAL TOPOGRAPHY SYSTEM
    K Number
    K923435
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1350
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Par Microsystems Corp.
    Date Received
    July 13, 1992
    Decision Date
    February 16, 1993
    Product Code
    HLQ
    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
    HLQ Keratoscope, Ac-Powered

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