{
  "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,
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  "results": [
    {
      "third_party_flag": "Y",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Eligible",
      "product_code": "OBN",
      "openfda": {
        "k_number": [
          "K070467"
        ]
      },
      "review_panel": "AN",
      "medical_specialty": "AN",
      "device_name": "Humidifier, Respiratory, Mask (Direct Patient Interface)",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Anesthesiology",
      "device_class": "2",
      "definition": "Intended to moderate blood pressure in hypertensive patients when they are exposed to the cold. The mask attenuates (moderates) the physiological response, increases in blood pressure, associated with cold exposure, by warming the inhaled air during cold exposure for individuals with hypertension, medicated or non-medicated.",
      "regulation_number": "868.5450",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}