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

    LASER IMAGING WORK STATION

    K Number: K897186 · Decision Mar 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    74

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    Basic Information

    Device Name
    LASER IMAGING WORK STATION
    K Number
    K897186
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1395
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Innovision Medical, Inc.
    Date Received
    December 28, 1989
    Decision Date
    March 12, 1990
    Product Code
    HJI
    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
    HJI Lens, Fundus, Hruby, Diagnostic

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