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

    AUTOMATIC PERIMETER, AP-340

    K Number: K881219 · Decision May 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    66
    Registration Numbers
    67
    Same Product Code
    40
    Applicant Total
    10
    Review Days
    42

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    Basic Information

    Device Name
    AUTOMATIC PERIMETER, AP-340
    K Number
    K881219
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1605
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Kowa Optimed, Inc.
    Date Received
    March 22, 1988
    Decision Date
    May 3, 1988
    Product Code
    HPT
    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
    HPT Perimeter, Automatic, Ac-Powered

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