{
  "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": "2026-07-27",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QMW",
      "openfda": {
        "k_number": [
          "DEN190047"
        ],
        "registration_number": [
          "3019252624",
          "3013791928",
          "3008773490"
        ],
        "fei_number": [
          "3019252624",
          "3013791928",
          "3008773490"
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      },
      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Coronary Artery Disease Risk Indicator From Acoustic Heart Signals",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "2",
      "definition": "A coronary artery disease risk indicator using acoustic heart signals is a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis.",
      "regulation_number": "870.1420",
      "implant_flag": "N",
      "submission_type_id": "1"
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  ]
}