{
  "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": "2026-06-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Stavanger",
      "advisory_committee_description": "Anesthesiology",
      "address_1": "Tanke Svilandsgate 30",
      "address_2": "P.O. Box 377",
      "statement_or_summary": "Summary",
      "product_code": "BTM",
      "openfda": {
        "device_name": "Ventilator, Emergency, Manual (Resuscitator)",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5915",
        "device_class": "2",
        "registration_number": [
          "3013557562",
          "3034669683",
          "3006061749",
          "1832562",
          "3014507910",
          "8021995",
          "3011137372",
          "3022631687",
          "9612374",
          "9617604",
          "8043316",
          "9710567",
          "3005609751",
          "3030308442",
          "3036470679",
          "9681848",
          "3011987967",
          "3010272829",
          "1417592",
          "3005587132",
          "2030745",
          "3012307300",
          "2022648",
          "2518436",
          "3027977504",
          "3008311916",
          "9610849",
          "3016761372",
          "3008806809",
          "3007734888",
          "3017708978",
          "3013484413",
          "3011503227",
          "2020813",
          "3003902679",
          "3008729547",
          "8044169",
          "9616445",
          "3006783791",
          "9610691",
          "1526863",
          "3031369651",
          "9610861",
          "3003898360",
          "3014656749",
          "8030673",
          "3038430561",
          "3003924186",
          "1314417",
          "3004111573",
          "2028807",
          "9610483",
          "3008261717",
          "3012104670",
          "3024753104",
          "3038772438",
          "3020460367",
          "3004993040",
          "2518157",
          "9616354",
          "9710391",
          "3008818980",
          "2024500",
          "3005621729",
          "1924066",
          "3010042047",
          "3006157842",
          "3015997711",
          "3003862188",
          "2648727",
          "3015191173",
          "3008264081",
          "3004365956",
          "3010402691",
          "1024404",
          "3014220748"
        ],
        "fei_number": [
          "3013557562",
          "3034669683",
          "3005747797",
          "3006061749",
          "1832562",
          "3014507910",
          "3022631687",
          "3004213967",
          "3002807391",
          "3005609751",
          "3002806359",
          "3030308442",
          "3036470679",
          "1000374126",
          "3011987967",
          "3002558692",
          "3005749238",
          "3010272829",
          "1417592",
          "3005587132",
          "3012307300",
          "3002807435",
          "2022648",
          "2518436",
          "3027977504",
          "3008311916",
          "3003202124",
          "3016761372",
          "3008806809",
          "3007734888",
          "3003319165",
          "3017708978",
          "3011503227",
          "3013484413",
          "2020813",
          "3008729547",
          "3003902679",
          "3006363476",
          "3006783791",
          "3002807836",
          "3003924186",
          "1526863",
          "3031369651",
          "3003898360",
          "3014656749",
          "3038430561",
          "1314417",
          "3004111573",
          "3024753104",
          "3008261717",
          "3012104670",
          "1000283452",
          "3000204983",
          "3003256355",
          "3038772438",
          "3020460367",
          "3004993040",
          "2518157",
          "3003418980",
          "3008818980",
          "2024500",
          "3005621729",
          "1924066",
          "3010042047",
          "3006157842",
          "3015997711",
          "3003862188",
          "2648727",
          "3002806674",
          "3000213164",
          "3015191173",
          "3008264081",
          "3004365956",
          "3010402691",
          "1024404",
          "3014220748"
        ]
      },
      "zip_code": "4002",
      "applicant": "Laerdal Medical AS",
      "decision_date": "2025-11-24",
      "decision_code": "SESE",
      "country_code": "NO",
      "device_name": "The BAG manual resuscitator and accessories",
      "advisory_committee": "AN",
      "contact": "Claudia  Pajares Ibanez",
      "expedited_review_flag": "",
      "k_number": "K251631",
      "state": "",
      "date_received": "2025-05-28",
      "review_advisory_committee": "AN",
      "postal_code": "4002",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}