{
  "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": "2026-04-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "Hsinchu County",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "3f., # 153, Ziqiang S. Rd., Zhubei City",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "DXH",
      "openfda": {
        "registration_number": [
          "",
          "1049754",
          "3010082909",
          "3001570235",
          "3023146633",
          "3012404027",
          "3012267350",
          "3008881376",
          "3005737664",
          "3014235520",
          "2031044",
          "3013681758",
          "3007184699",
          "1527715",
          "9617277",
          "3008820594",
          "3002808458",
          "3010742884",
          "3010381606",
          "3013689228",
          "1000425315",
          "9610105",
          "2017865",
          "3014982325",
          "3015976873",
          "3013250653",
          "3000130829",
          "9710602",
          "3008293988",
          "3008729547",
          "3008881835",
          "3010097171",
          "8030245",
          "2133641",
          "3042928308",
          "3000126629",
          "3006418479",
          "3004035727",
          "3003174284",
          "3006371704",
          "3019388613",
          "9611045",
          "3016618143",
          "3013684844",
          "3010399798",
          "3012516456",
          "3011937459",
          "3010363430",
          "2000004234",
          "1218950",
          "3013164281",
          "3011235999",
          "3014522540",
          "3010157426",
          "3015134086",
          "3021422553",
          "3032536454",
          "3018094310",
          "1450057",
          "3011265784",
          "3021769057",
          "3010419931",
          "3027815",
          "3001149827",
          "3007734888",
          "3017942784",
          "3015185344",
          "9680510",
          "9611295",
          "3012359877",
          "3012302888",
          "3012528160",
          "3032109181",
          "3007208829",
          "3009715978",
          "3013188547",
          "3003647588",
          "3001373226",
          "2182208",
          "3013896610"
        ],
        "fei_number": [
          "",
          "1049754",
          "3010082909",
          "3001570235",
          "3023146633",
          "3012404027",
          "3012267350",
          "3008881376",
          "3005737664",
          "3014235520",
          "3013681758",
          "3007184699",
          "1527715",
          "3008820594",
          "3002808458",
          "3010742884",
          "3010381606",
          "3013689228",
          "1000425315",
          "2017865",
          "3014982325",
          "3015976873",
          "3013250653",
          "3000130829",
          "3001236763",
          "3008293988",
          "3008729547",
          "3008881835",
          "3003190524",
          "3010097171",
          "3042928308",
          "3000126629",
          "1000127185",
          "3006418479",
          "3004035727",
          "3003174284",
          "3006371704",
          "3004072282",
          "3019388613",
          "3016618143",
          "3003708031",
          "3013684844",
          "3010399798",
          "3012516456",
          "3002806783",
          "3011937459",
          "3010363430",
          "2000004234",
          "1218950",
          "3013164281",
          "3003513129",
          "3011235999",
          "3014522540",
          "3010157426",
          "3015134086",
          "3021422553",
          "3032536454",
          "3018094310",
          "1450057",
          "3011265784",
          "3021769057",
          "3010419931",
          "3001149827",
          "3007734888",
          "3017942784",
          "3015185344",
          "3012359877",
          "3002807992",
          "3012302888",
          "3002807674",
          "3000203466",
          "3012528160",
          "3032109181",
          "3007208829",
          "3009715978",
          "3013188547",
          "3003647588",
          "3001373226",
          "2182208",
          "3013896610"
        ],
        "device_name": "Transmitters And Receivers, Electrocardiograph, Telephone",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2920",
        "device_class": "2"
      },
      "zip_code": "302042",
      "applicant": "VitalSigns Technology Co., Ltd.",
      "decision_date": "2025-06-17",
      "decision_code": "SESE",
      "country_code": "TW",
      "device_name": "VitalSigns 1-Lead Holter (VSH101)",
      "advisory_committee": "CV",
      "contact": "Jih-liang  Juang",
      "expedited_review_flag": "",
      "k_number": "K243003",
      "state": "",
      "date_received": "2024-09-26",
      "review_advisory_committee": "CV",
      "postal_code": "302042",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}