{
  "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": "2026-10-26",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "proprietary_name": [
        "NeuroSENSE Monitoring System, Model NS-901, with EasyPrep Electrodes EK-901"
      ],
      "establishment_type": [
        "Manufacture Medical Device"
      ],
      "registration": {
        "registration_number": "3008657519",
        "fei_number": "3008657519",
        "status_code": "1",
        "initial_importer_flag": "N",
        "reg_expiry_date_year": "2026",
        "name": "NEUROWAVE SYSTEMS INC.",
        "address_line_1": "25825 Science Park Dr, STE 250",
        "address_line_2": "",
        "city": "Beachwood",
        "state_code": "OH",
        "iso_country_code": "US",
        "zip_code": "44122",
        "postal_code": "",
        "us_agent": {},
        "owner_operator": {
          "firm_name": "NeuroWave Systems Inc.",
          "owner_operator_number": "10033810",
          "official_correspondent": {
            "first_name": "Tatjana",
            "middle_initial": "",
            "last_name": "Zikov",
            "subaccount_company_name": "",
            "phone_number": "x-216-3611591-337"
          },
          "contact_address": {
            "address_1": "25825 Science Park, STE 250",
            "address_2": "",
            "city": "Beachwood",
            "state_code": "OH",
            "state_province": "",
            "iso_country_code": "US",
            "postal_code": "44122"
          }
        }
      },
      "pma_number": "",
      "k_number": "K202621",
      "products": [
        {
          "product_code": "OLW",
          "created_date": "2022-11-21",
          "owner_operator_number": "10033810",
          "exempt": "",
          "openfda": {
            "k_number": [
              "K202621"
            ],
            "device_name": "Index-Generating Electroencephalograph Software",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.1400",
            "device_class": "2"
          }
        },
        {
          "product_code": "ORT",
          "created_date": "2022-11-21",
          "owner_operator_number": "10033810",
          "exempt": "",
          "openfda": {
            "device_name": "Burst Suppression Detection Software For Electroencephalograph",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.1400",
            "device_class": "2"
          }
        },
        {
          "product_code": "GXY",
          "created_date": "2022-11-21",
          "owner_operator_number": "10033810",
          "exempt": "",
          "openfda": {
            "device_name": "Electrode, Cutaneous",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.1320",
            "device_class": "2"
          }
        },
        {
          "product_code": "OMC",
          "created_date": "2022-11-21",
          "owner_operator_number": "10033810",
          "exempt": "",
          "openfda": {
            "device_name": "Reduced- Montage Standard Electroencephalograph",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.1400",
            "device_class": "2"
          }
        },
        {
          "product_code": "OLT",
          "created_date": "2022-11-21",
          "owner_operator_number": "10033810",
          "exempt": "",
          "openfda": {
            "device_name": "Non-Normalizing Quantitative Electroencephalograph Software",
            "medical_specialty_description": "Neurology",
            "regulation_number": "882.1400",
            "device_class": "2"
          }
        }
      ]
    }
  ]
}