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

    AEYE-DS

    K Number: K240058 · Decision Apr 23, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    106

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    Basic Information

    Device Name
    AEYE-DS
    K Number
    K240058
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1100
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aeye Health, Inc.
    Date Received
    January 8, 2024
    Decision Date
    April 23, 2024
    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 Aeye Health, Inc.

    K Number Device Name
    K221183 AEYE-DS