{
  "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": {
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  "results": [
    {
      "third_party_flag": "N",
      "city": "Austin",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "4020 S. Industrial Dr.",
      "address_2": "Suite 160",
      "statement_or_summary": "Summary",
      "product_code": "DTY",
      "openfda": {
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          "2184009",
          "2011171",
          "1828100",
          "1422634"
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          "1928237",
          "1000116158",
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          "1000514656",
          "2011171"
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        "device_name": "Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4410",
        "device_class": "2"
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      "zip_code": "78744",
      "applicant": "International Biophysics Corp.",
      "decision_date": "1997-03-20",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "CM02 CUVETTE, 1/2, CM02 CUVETTE, 3/8 AND CM02 CUVETTE, 1/4",
      "advisory_committee": "CV",
      "contact": "H. DAVID  SHOCKLEY, JR.",
      "expedited_review_flag": "",
      "k_number": "K963698",
      "state": "TX",
      "date_received": "1996-09-16",
      "review_advisory_committee": "CV",
      "postal_code": "78744",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
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}