{
  "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": "Eagan",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "1285 Corporate Center Dr.",
      "address_2": "Suite 150",
      "statement_or_summary": "Statement",
      "product_code": "MWJ",
      "openfda": {
        "registration_number": [
          "3016618143",
          "3014848734",
          "2028530",
          "3007184699",
          "3008977358",
          "3010844918",
          "3004006614",
          "1000122786",
          "3009443693",
          "3013596024",
          "3010222749",
          "3004009431",
          "1316463",
          "3006087789",
          "3008413470",
          "3010082909",
          "3012528160",
          "3017446092",
          "3004035727",
          "3012027770",
          "3035371769",
          "1126271",
          "3009499478",
          "3013500228",
          "3010381606",
          "3008159616",
          "3007770164",
          "3010552191",
          "1527715",
          "2133641",
          "1000165971",
          "3003971136",
          "3016406615",
          "9611295",
          "9610816",
          "3015185344",
          "3013889955",
          "3011883032",
          "3043479346",
          "3014235520",
          "3008717264",
          "3009077524",
          "9681548",
          "3010157426",
          "1218950",
          "3010390468",
          "3016701404",
          "3032906215",
          "3015529350",
          "1224919"
        ],
        "fei_number": [
          "3016618143",
          "3014848734",
          "3007184699",
          "3000203466",
          "3008977358",
          "3010844918",
          "3004006614",
          "1000122786",
          "3009443693",
          "3013596024",
          "3010222749",
          "3004009431",
          "1316463",
          "3006087789",
          "3008413470",
          "3010082909",
          "3012528160",
          "3017446092",
          "3004035727",
          "3012027770",
          "3035371769",
          "3009499478",
          "3013500228",
          "3010381606",
          "3008159616",
          "3007770164",
          "1527715",
          "1000165971",
          "3003971136",
          "3016406615",
          "3015185344",
          "1000263641",
          "3013889955",
          "3011883032",
          "3002807745",
          "3043479346",
          "3002807167",
          "3014235520",
          "3008717264",
          "3009077524",
          "3010157426",
          "1000125122",
          "3015191855",
          "1218950",
          "3010390468",
          "3016701404",
          "3032906215",
          "3015529350",
          "3002807992",
          "1000513706"
        ],
        "device_name": "Electrocardiograph, Ambulatory (Without Analysis)",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2800",
        "device_class": "2"
      },
      "zip_code": "55121",
      "applicant": "Braemar, Inc.",
      "decision_date": "2007-04-27",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER",
      "advisory_committee": "CV",
      "contact": "DARREN  DERSHEM",
      "expedited_review_flag": "",
      "k_number": "K071011",
      "state": "MN",
      "date_received": "2007-04-10",
      "review_advisory_committee": "CV",
      "postal_code": "55121",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Special"
    }
  ]
}