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

    MACULAR FUNCTION ANALYZER

    K Number: K843227 · Decision Jul 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    56
    Review Days
    340

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    Basic Information

    Device Name
    MACULAR FUNCTION ANALYZER
    K Number
    K843227
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1330
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Danek Medical, Inc.
    Date Received
    August 16, 1984
    Decision Date
    July 22, 1985
    Product Code
    HOQ
    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
    HOQ Grid, Amsler

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