{
  "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": "Fremont",
      "advisory_committee_description": "Neurology",
      "address_1": "47102 Mission Falls Ct.",
      "address_2": "Suite 210",
      "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": "94539",
      "applicant": "Neumetry Medical, Inc.",
      "decision_date": "2022-09-21",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "SomnoMetry",
      "advisory_committee": "NE",
      "contact": "Paul  Chen",
      "expedited_review_flag": "",
      "k_number": "K221179",
      "state": "CA",
      "date_received": "2022-04-25",
      "review_advisory_committee": "NE",
      "postal_code": "94539",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}