{
  "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": "Plymouth",
      "advisory_committee_description": "Cardiovascular",
      "address_1": "12505 58th Ave. N.",
      "address_2": "",
      "statement_or_summary": "Statement",
      "product_code": "MLO",
      "openfda": {
        "registration_number": [
          "3010381606",
          "3008717264",
          "3006948155",
          "3016701404",
          "1316463",
          "1218950",
          "3012528160",
          "3000126629",
          "3016618143",
          "3021988268",
          "3014522540",
          "3010390468",
          "1063925",
          "3007184699",
          "3010082909",
          "3023146633",
          "3008799846",
          "3012302888",
          "3006087789",
          "3006979678",
          "1000425315",
          "3008977358",
          "3032536454",
          "3011937459",
          "9681548",
          "3012027770",
          "3017840980",
          "3005737664",
          "3016406615",
          "1126271",
          "1033601"
        ],
        "fei_number": [
          "3010381606",
          "3008717264",
          "3002807745",
          "3016701404",
          "1316463",
          "3002459124",
          "1218950",
          "3012528160",
          "3000126629",
          "3016618143",
          "3021988268",
          "1000263641",
          "3014522540",
          "3010390468",
          "3007184699",
          "3010082909",
          "3023146633",
          "3009865005",
          "3008799846",
          "3012302888",
          "3006087789",
          "3006979678",
          "1000425315",
          "3008977358",
          "3032536454",
          "3011937459",
          "3012027770",
          "3017840980",
          "3005737664",
          "3016406615",
          "1033601"
        ],
        "device_name": "Electrocardiograph, Ambulatory, With Analysis Algorithm",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2800",
        "device_class": "2"
      },
      "zip_code": "55442",
      "applicant": "Norav Medical , Ltd.",
      "decision_date": "2002-05-08",
      "decision_code": "SESE",
      "country_code": "US",
      "device_name": "NORAV HOLTER SYSTEM, MODEL NH-300 V1.07",
      "advisory_committee": "CV",
      "contact": "STEVE  SPRINGROSE",
      "expedited_review_flag": "",
      "k_number": "K012712",
      "state": "MN",
      "date_received": "2001-08-14",
      "review_advisory_committee": "CV",
      "postal_code": "55442",
      "decision_description": "Substantially Equivalent",
      "clearance_type": "Traditional"
    }
  ]
}