{
  "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": "2026-11-02",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "PGE",
      "openfda": {
        "pma_number": [
          "P110015"
        ],
        "registration_number": [
          "3011592854",
          "3010031043"
        ],
        "fei_number": [
          "3010484784",
          "3009091796"
        ]
      },
      "review_panel": "TX",
      "medical_specialty": "",
      "device_name": "Gastric Emptying Breath Test",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Unknown",
      "device_class": "3",
      "definition": "Gastric emptying breath tests are intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis.The test system typically utilizes a Mass Spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples following the ingestion of a 13C-labeled test meal.",
      "regulation_number": "",
      "implant_flag": "N",
      "submission_type_id": "2"
    }
  ]
}