{
  "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": "2026-07-27",
    "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": "QVE",
      "openfda": {
        "k_number": [
          "DEN210022"
        ],
        "registration_number": [
          "1930027",
          "3015509718",
          "3011782009"
        ],
        "fei_number": [
          "1930027",
          "3010666513",
          "3015509718"
        ]
      },
      "review_panel": "AN",
      "medical_specialty": "AN",
      "device_name": "Adjunctive Pain Measurement Device For Anesthesiology",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Anesthesiology",
      "device_class": "2",
      "definition": "An adjunctive pain measurement device for anesthesiology is a prescription device that includes software algorithms to analyze physiological sensor data and measure response to painful stimuli in patients under general anesthesia. The device may be software-only or it may include hardware such as physiological sensors. This device type is intended for adjunctive use to tailor analgesic administration to a patient’s actual response to painful stimuli and is not intended to independently direct decision-making.",
      "regulation_number": "868.2200",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}