{
  "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": "Madison",
      "advisory_committee_description": "Neurology",
      "address_1": "555 D'Onofrio Dr.",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "OLV",
      "openfda": {
        "device_name": "Standard Polysomnograph With Electroencephalograph",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.1400",
        "device_class": "2",
        "registration_number": [
          "3007389703",
          "8030229",
          "3002797442",
          "9613619",
          "3030154814",
          "3016852448",
          "3020018",
          "3009770872",
          "1650946",
          "1530224",
          "3010611950",
          "9617286",
          "9611252",
          "2023374",
          "3018783526",
          "3021736577",
          "3007323246",
          "3001687738",
          "3007962724",
          "9710486",
          "3006125362",
          "3008881376",
          "2184161",
          "3007616088",
          "3038189172",
          "3006258337",
          "3012428212",
          "3008253300",
          "3015491430",
          "9615102",
          "2080783",
          "3006418479",
          "3000126629",
          "9612330",
          "3004964738",
          "3005550372",
          "2518422",
          "3013501110",
          "1529102",
          "3002806730",
          "3026753386",
          "3011120183",
          "1063925",
          "3006177498",
          "3023272766",
          "3005733633",
          "3027726372"
        ],
        "fei_number": [
          "3007389703",
          "3002797442",
          "3030154814",
          "3016852448",
          "3002807739",
          "3020018",
          "3009770872",
          "3010611950",
          "2023374",
          "3018783526",
          "3021736577",
          "3007323246",
          "3002459124",
          "3001687738",
          "3007962724",
          "3006125362",
          "3008881376",
          "3007616088",
          "3002807720",
          "3038189172",
          "3006258337",
          "3012428212",
          "3008253300",
          "3015491430",
          "3002809369",
          "2080783",
          "1000139867",
          "3006418479",
          "3000126629",
          "3004964738",
          "3005550372",
          "2518422",
          "3013501110",
          "3003501123",
          "3000206198",
          "3002806730",
          "3026753386",
          "3003208775",
          "3002716534",
          "1000271197",
          "1000160007",
          "3004674371",
          "3011120183",
          "3023272766",
          "3006177498",
          "3005733633",
          "3027726372"
        ]
      },
      "zip_code": "53719",
      "applicant": "Lamont Medical, Inc.",
      "decision_date": "1999-05-19",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS",
      "advisory_committee": "NE",
      "contact": "TONY  MONTGOMERY",
      "expedited_review_flag": "",
      "k_number": "K990522",
      "state": "WI",
      "date_received": "1999-02-18",
      "review_advisory_committee": "NE",
      "postal_code": "53719",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}