{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QXO",
      "openfda": {
        "k_number": [
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      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Cardiovascular Machine Learning-Based Notification Software",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "2",
      "definition": "Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a   cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.",
      "regulation_number": "870.2380",
      "implant_flag": "N",
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}