{
  "meta": {
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-14",
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    {
      "pma_number": "P850064",
      "supplement_number": "S034",
      "applicant": "Bunnell, Inc.",
      "street_1": "436 Lawndale Dr.",
      "street_2": "",
      "city": "Salt Lake City",
      "state": "UT",
      "zip": "84115",
      "zip_ext": "",
      "generic_name": "VENTILATOR, HIGH FREQUENCY",
      "trade_name": "Life Pulse High Frequency Ventilator",
      "product_code": "LSZ",
      "advisory_committee": "AN",
      "advisory_committee_description": "Anesthesiology",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2017-06-07",
      "decision_date": "2017-07-06",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "Change to the test equipment used for the testing during manufacturing and servicing of the finished Life Pulse High Frequency Ventilator.",
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        "device_name": "Ventilator, High Frequency",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
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