{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Kungsbacka",
      "advisory_committee_description": "Gastroenterology, Urology",
      "address_1": "Faktorvagen 13",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "MSB",
      "openfda": {
        "registration_number": [
          "3007685782",
          "3003708554",
          "9615922",
          "2123774",
          "3011175555",
          "1220477",
          "3003152463",
          "3031884833",
          "3007583504",
          "3024820181",
          "3010034260",
          "3010765841",
          "1047843",
          "3017223202",
          "1420032"
        ],
        "fei_number": [
          "3007685782",
          "3003708554",
          "2123774",
          "3011175555",
          "1220477",
          "3003152463",
          "3031884833",
          "3007583504",
          "3024820181",
          "3010034260",
          "3010765841",
          "1047843",
          "3001640191",
          "3017223202",
          "1420032"
        ],
        "device_name": "System And Accessories, Isolated Heart, Transport And Preservation",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5880",
        "device_class": "2"
      },
      "zip_code": "SE-434 37",
      "applicant": "Vitrolife Sweden AB",
      "decision_date": "2008-10-09",
      "decision_code": "SESE",
      "country_code": "SE",
      "device_name": "PERFADEX WITH THAM",
      "advisory_committee": "GU",
      "contact": "KJELL  KJORK",
      "expedited_review_flag": "",
      "k_number": "K081997",
      "state": "",
      "date_received": "2008-07-14",
      "review_advisory_committee": "GU",
      "postal_code": "SE-434 37",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
    }
  ]
}