{
  "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": "San Jose",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "200 Ringwood Ave.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NCX",
      "openfda": {
        "registration_number": [
          "2024311",
          "2029275",
          "3029871637",
          "3010617000"
        ],
        "fei_number": [
          "3003793491",
          "3029871637",
          "1000306431",
          "2024311"
        ],
        "device_name": "System, Hypothermia, Intravenous, Cooling",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5900",
        "device_class": "2"
      },
      "zip_code": "95131",
      "applicant": "Zoll Circulation, Inc.",
      "decision_date": "2021-12-20",
      "decision_code": "SESU",
      "country_code": "US",
      "device_name": "Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console",
      "advisory_committee": "CV",
      "contact": "Elizabeth  Haines",
      "expedited_review_flag": "",
      "k_number": "K213031",
      "state": "CA",
      "date_received": "2021-09-21",
      "review_advisory_committee": "NE",
      "postal_code": "95131",
      "decision_description": "Unknown",
      "clearance_type": "Traditional"
    }
  ]
}