BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EyeArt

    K Number: K200667 · Decision Aug 3, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    143

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    Basic Information

    Device Name
    EyeArt
    K Number
    K200667
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1100
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Eyenuk, Inc.
    Date Received
    March 13, 2020
    Decision Date
    August 3, 2020
    Product Code
    PIB
    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
    PIB Diabetic Retinopathy Detection Device

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    Other Clearances by Eyenuk, Inc.

    K Number Device Name
    K223357 EyeArt v2.2.0