BEUDAMED
    Product Code: HOK FDA class 1 21 CFR 886.1810

    Screen, Tangent, Projection, Ac-Powered

    Ophthalmic

    An AC-Powered Projection Tangent Screen is an electrically powered ophthalmic diagnostic device that projects targets onto a flat screen surface for use in mapping the central visual field, enabling detection of scotomas and other visual field abnormalities. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HOK and is regulated under 21 CFR 886.1810, within the Ophthalmic medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HOK
    Device Class
    FDA class 1
    Regulation Number
    886.1810
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K914896 FRIEDMANN ANALYSER 3

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.