BEUDAMED
    Product Code: HRK FDA class 1 21 CFR 886.4855

    Table, Instrument, Manual, Ophthalmic

    Ophthalmic

    A Manual Ophthalmic Instrument Table is a non-powered adjustable table or stand designed to hold ophthalmic diagnostic instruments at a convenient height and position for use during eye examinations, adjusted manually rather than by a powered mechanism. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HRK and is regulated under 21 CFR 886.4855, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.

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    510(k)s
    2
    FEI Numbers
    13
    Registration Numbers
    13
    Unique Applicants
    2
    Years Active
    8

    Basic Information

    Product Code
    HRK
    Device Class
    FDA class 1
    Regulation Number
    886.4855
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K842410 AMER. EDWARDS LAB FLEXISCOPE
    K760697 EVANS ARM AND HAND REST

    FEI Numbers

    This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.