BEUDAMED
    Product Code: HOW FDA class 1 21 CFR 886.1200

    Drum, Opticokinetic

    Ophthalmic

    An Optokinetic Drum is a diagnostic ophthalmic instrument consisting of a rotating cylinder with alternating stripes used to elicit optokinetic nystagmus, a reflexive eye movement, for assessing visual acuity in non-verbal patients and evaluating afferent visual pathway integrity. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification. It carries product code HOW and is regulated under 21 CFR 886.1200, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.

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    510(k)s
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    HOW
    Device Class
    FDA class 1
    Regulation Number
    886.1200
    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
    K822917 MODEL 5400 OPTOKINETIC STIMULATOR

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.