{
  "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": 2
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Sweden",
      "advisory_committee_description": "Obstetrics/Gynecology",
      "address_1": "Fullriggaregatan 12 B",
      "address_2": "S-421 74 V.Frolunda",
      "statement_or_summary": "",
      "product_code": "HEM",
      "openfda": {
        "registration_number": [
          "3007766601"
        ],
        "fei_number": [
          "3007766601"
        ],
        "device_name": "Imager, Ultrasonic Obstetric-Gynecologic",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.2225",
        "device_class": "2"
      },
      "zip_code": "",
      "applicant": "Swemed Laboratories, Inc.",
      "decision_date": "1986-08-19",
      "decision_code": "SN",
      "country_code": "SE",
      "device_name": "NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)",
      "advisory_committee": "OB",
      "contact": "GORAN  ITSKOWITZ",
      "expedited_review_flag": "",
      "k_number": "K862364",
      "state": "",
      "date_received": "1986-06-24",
      "review_advisory_committee": "OB",
      "postal_code": "",
      "decision_description": "Substantially Equivalent for Some Indications",
      "clearance_type": "Traditional"
    }
  ]
}