{
  "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,
      "total": 1
    }
  },
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      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
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      "definition": "This device is a non-wearable prescription use only aed.  These are devices that include automated external defibrillation.  Automated external defibrillators use external pad-type electrodes to sense, detect, classify and treat (with an electrical shock) ventricular fibrillation.  These devices are intended to be used on suspected victims of sudden cardiac arrest.  A person in cardiac arrest is unresponsive and is not breathing normally.  The device can be sold with prescription only.",
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}