{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-06-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QEA",
      "openfda": {
        "k_number": [
          "K242116",
          "K254086",
          "K212310",
          "K191183",
          "K201841",
          "DEN170091",
          "K202927"
        ],
        "registration_number": [
          "3014535677",
          "3014133165"
        ],
        "fei_number": [
          "3014535677",
          "3014133165"
        ]
      },
      "review_panel": "NE",
      "medical_specialty": "NE",
      "device_name": "Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Neurology",
      "device_class": "2",
      "definition": "A traumatic brain injury eye movement assessment aid is a prescription device that uses a patient’s tracked eye movements to provide an interpretation of the functional condition of the patient’s brain. This device is an assessment aid that is not intended for standalone detection or diagnostic purposes.",
      "regulation_number": "882.1455",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}