{
  "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": "Skovlunde",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "16-18 Tonsbakken",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "FFX",
      "openfda": {
        "device_name": "System, Gastrointestinal Motility (Electrical)",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1725",
        "device_class": "2",
        "registration_number": [
          "3007662958",
          "3018094310",
          "3012302888",
          "3008361498",
          "3016544248",
          "2023374",
          "9611668",
          "3017448360",
          "3016854619",
          "3035451914",
          "1836324",
          "3010082909",
          "9710107",
          "3009106214",
          "1126271",
          "1119033",
          "3015198783",
          "3010381606",
          "3004904811",
          "3013973539",
          "3002806603",
          "3011790297",
          "1123137",
          "3008717264",
          "3009445917",
          "9681384",
          "3008414621",
          "8020893",
          "3012480535",
          "3002821211",
          "9611896"
        ],
        "fei_number": [
          "3007662958",
          "3018094310",
          "3012302888",
          "3009293069",
          "3008361498",
          "3016544248",
          "2023374",
          "3017448360",
          "3016854619",
          "3035451914",
          "3010082909",
          "3002807850",
          "3009106214",
          "1119033",
          "3015198783",
          "3010381606",
          "3002807135",
          "3004904811",
          "3013973539",
          "1000123180",
          "3002806603",
          "3002998595",
          "3011790297",
          "3003348376",
          "1000263641",
          "3008717264",
          "3002807626",
          "3002957361",
          "3008414621",
          "3012480535",
          "3002821211"
        ]
      },
      "zip_code": "DK-2740",
      "applicant": "Medtronic Functional Diagnostics A/S",
      "decision_date": "2001-08-10",
      "decision_code": "SESE",
      "country_code": "DK",
      "device_name": "POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID",
      "advisory_committee": "GU",
      "contact": "TOVE  KJAER",
      "expedited_review_flag": "",
      "k_number": "K011472",
      "state": "",
      "date_received": "2001-05-14",
      "review_advisory_committee": "GU",
      "postal_code": "DK-2740",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}