{
  "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": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Waldems",
      "advisory_committee_description": "General Hospital",
      "address_1": "Auf Der Lind 10",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "FRC",
      "openfda": {
        "registration_number": [
          "2029076",
          "3004634710",
          "3013557562",
          "3036504234",
          "3038718579",
          "3013667284",
          "3030626857",
          "1416605",
          "3013298431",
          "3031757047",
          "2183301",
          "3011061109",
          "3009968482",
          "3014579161",
          "3031841433",
          "3013145340",
          "3004080920",
          "3043226252",
          "2434982",
          "3012723641",
          "3014421917",
          "2028456",
          "8030087",
          "1720309",
          "3009609218",
          "2432141",
          "2133641",
          "3016678045",
          "3012421607",
          "1319130",
          "3000251274",
          "3012494290",
          "2410251",
          "9611959",
          "2084725",
          "3003476474",
          "3017524825",
          "3030733800",
          "3042272797",
          "3016075971",
          "3015392401",
          "3007412809"
        ],
        "fei_number": [
          "3004634710",
          "3013557562",
          "3036504234",
          "3038718579",
          "3013667284",
          "3030626857",
          "1416605",
          "3002677549",
          "3013298431",
          "3031757047",
          "2183301",
          "3005343391",
          "3011061109",
          "3009968482",
          "3014579161",
          "3031841433",
          "3013145340",
          "3004080920",
          "1000125215",
          "3043226252",
          "2434982",
          "3014421917",
          "3009609218",
          "2432141",
          "1720309",
          "1000160630",
          "3016678045",
          "3012421607",
          "3003662624",
          "1319130",
          "3000203466",
          "3000251274",
          "3012494290",
          "3014534",
          "2410251",
          "3003476474",
          "3017524825",
          "3030733800",
          "3042272797",
          "3016075971",
          "3015392401",
          "3007412809"
        ],
        "device_name": "Indicator, Biological Sterilization Process",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.2800",
        "device_class": "2"
      },
      "zip_code": "65529",
      "applicant": "Gke-GmbH",
      "decision_date": "2017-04-07",
      "decision_code": "SESE",
      "country_code": "DE",
      "device_name": "gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)",
      "advisory_committee": "HO",
      "contact": "Ulrich  Kaiser",
      "expedited_review_flag": "",
      "k_number": "K163144",
      "state": "",
      "date_received": "2016-11-09",
      "review_advisory_committee": "HO",
      "postal_code": "65529",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}