{
  "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": "2026-10-12",
    "results": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Irvine",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "15770 Laguna Canyon, Suite 150",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "NCX",
      "openfda": {
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          "3010617000",
          "2029275",
          "3029871637"
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          "1000306431",
          "3003793491",
          "3029871637"
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        "device_name": "System, Hypothermia, Intravenous, Cooling",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5900",
        "device_class": "2"
      },
      "zip_code": "92618",
      "applicant": "Alsius Corp.",
      "decision_date": "2003-08-01",
      "decision_code": "SESU",
      "country_code": "US",
      "device_name": "COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D",
      "advisory_committee": "CV",
      "contact": "KEN  COLLINS",
      "expedited_review_flag": "",
      "k_number": "K014241",
      "state": "CA",
      "date_received": "2001-12-26",
      "review_advisory_committee": "NE",
      "postal_code": "92618",
      "decision_description": "Unknown",
      "clearance_type": "Traditional"
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}