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

    EyeCTester

    K Number: K203594 · Decision Sep 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    637

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    Basic Information

    Device Name
    EyeCTester
    K Number
    K203594
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1330
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuro-Eye Diagnostic Systems, LLC
    Date Received
    December 9, 2020
    Decision Date
    September 7, 2022
    Product Code
    QTW
    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
    QTW Digital Amsler Grid