BEUDAMED
    Product Code: HRJ FDA class 1 21 CFR 886.4855

    Table, Instrument, Powered, Ophthalmic

    Ophthalmic

    A Powered Ophthalmic Instrument Table is an electrically adjustable table or stand designed to support ophthalmic diagnostic instruments and provide ergonomic positioning for both clinician and patient during eye examinations and procedures. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification or approval. It carries product code HRJ and is regulated under 21 CFR 886.4855, within the Ophthalmic medical specialty.

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    510(k)s
    7
    FEI Numbers
    54
    Registration Numbers
    55
    Unique Applicants
    7
    Years Active
    10

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    Basic Information

    Product Code
    HRJ
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K930447 MARCO H AND TS-1 INSTRUMENT TABLES
    K922242 910T MONTORIZED INSTRUMENT TABLE
    K912134 TBD, LENS MEASURING DEVICE
    K853744 TECHNA VISION, INC.ELECTRIC TABLE
    K853359 RELIANCE 1379
    K841760 WOODLYN CLASSIC INSTRUMENT STAND
    K833820 MACHEMER/TANO ROTATING

    FEI Numbers

    This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.