{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Dundas",
      "advisory_committee_description": "Neurology",
      "address_1": "17 Lantern Ln.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "OLZ",
      "openfda": {
        "registration_number": [
          "3007389703",
          "3002797442",
          "9613619",
          "3009770872",
          "1650946",
          "3010611950",
          "3033526676",
          "3018783526",
          "3033708293",
          "3007616088",
          "3013724298",
          "3012428212",
          "3008253300",
          "3010399798",
          "3000126629",
          "9612330",
          "3004964738",
          "2518422",
          "3026753386",
          "3011120183",
          "1063925",
          "3023272766",
          "3027726372"
        ],
        "fei_number": [
          "3007389703",
          "3002797442",
          "3009770872",
          "3010611950",
          "3033526676",
          "3018783526",
          "3002459124",
          "3033708293",
          "3007616088",
          "3013724298",
          "3012428212",
          "3008253300",
          "3002809369",
          "3010399798",
          "3000126629",
          "3004964738",
          "2518422",
          "3026753386",
          "3002716534",
          "3004674371",
          "3011120183",
          "3023272766",
          "3027726372"
        ],
        "device_name": "Automatic Event Detection Software For Polysomnograph With Electroencephalograph",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1400",
        "device_class": "2"
      },
      "zip_code": "L9H 6N9",
      "applicant": "Neurozone Msh Incorporated",
      "decision_date": "2019-01-17",
      "decision_code": "SESE",
      "country_code": "CA",
      "device_name": "Esprit Nova",
      "advisory_committee": "NE",
      "contact": "Daniel Ramirez Rodriguez",
      "expedited_review_flag": "",
      "k_number": "K182227",
      "state": "",
      "date_received": "2018-08-16",
      "review_advisory_committee": "NE",
      "postal_code": "L9H 6N9",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}