BEUDAMED
    Product Code: NEQ FDA class 2 21 CFR 876.1500

    Device, Telemedicine, Robotic

    Gastroenterology, Urology

    The Device, Telemedicine, Robotic (product code NEQ) is a robotic telemedicine system that enables remote clinical examination or consultation, combining robotic mobility or manipulation with real-time audio-visual communication between clinicians and patients. It is classified as an FDA Class 2 device within the Gastroenterology and Urology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    0

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    Basic Information

    Product Code
    NEQ
    Device Class
    FDA class 2
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    SU
    Submission Type
    1

    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
    K013804 SOCRATES ROBOTIC TELEMONITORING SYSTEM
    K003661 SOCRATES ROBOTIC TELEMONITORING SYSTEM