BEUDAMED
    Product Code: HOL FDA class 1 21 CFR 886.1810

    Screen, Tangent, Felt (Campimeter)

    Ophthalmic

    A Felt Tangent Screen (Campimeter) is a manual ophthalmic diagnostic instrument consisting of a black felt surface used for measuring the central visual field by detecting the patient's response to targets moved across the screen, allowing identification of field defects. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket submission. It carries product code HOL and is regulated under 21 CFR 886.1810, within the Ophthalmic medical specialty.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HOL
    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

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.