{
  "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
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "life_sustain_support_flag": "N",
      "gmp_exempt_flag": "N",
      "summary_malfunction_reporting": "Ineligible",
      "product_code": "QYU",
      "openfda": {
        "k_number": [
          "K234021",
          "DEN220091"
        ],
        "registration_number": [
          "3004415095",
          "3012977166",
          "3019388613",
          "3003899230",
          "3011353843"
        ],
        "fei_number": [
          "3004415095",
          "3012977166",
          "3019388613",
          "3003899230",
          "3011353843"
        ]
      },
      "review_panel": "CV",
      "medical_specialty": "CV",
      "device_name": "Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter Use",
      "review_code": "",
      "unclassified_reason": "",
      "medical_specialty_description": "Cardiovascular",
      "device_class": "2",
      "definition": "An infant pulse rate and oxygen saturation monitor for over-the-counter use is a device that uses photoplethysmography to measure pulse rate and oxygen saturation in infants. The device may contain alarms that alert the caregiver when vital sign(s) go outside preset threshold(s).",
      "regulation_number": "870.2705",
      "implant_flag": "N",
      "submission_type_id": "1"
    }
  ]
}