{
  "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": "2026-07-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Uppsala",
      "advisory_committee_description": "Clinical Chemistry",
      "address_1": "Danmarksgatan 26",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "QEI",
      "openfda": {
        "registration_number": [
          "3013887826"
        ],
        "fei_number": [
          "3013887826"
        ],
        "device_name": "Breast Milk Macronutrients Test System",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1493",
        "device_class": "2"
      },
      "zip_code": "75323",
      "applicant": "Miris AB",
      "decision_date": "2023-09-29",
      "decision_code": "SESE",
      "country_code": "SE",
      "device_name": "Miris Human Milk Analyzer (HMA)",
      "advisory_committee": "CH",
      "contact": "Elin  Hallen",
      "expedited_review_flag": "",
      "k_number": "K223085",
      "state": "",
      "date_received": "2022-09-30",
      "review_advisory_committee": "CH",
      "postal_code": "75323",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}