{
  "format": "devicerts.device.v1",
  "cite_as": "Avazzia, Avazzia, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/avazzia-nuh (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/avazzia-nuh",
    "json_url": "https://devicerts.com/devices/avazzia-nuh.json",
    "markdown_url": "https://devicerts.com/devices/avazzia-nuh.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-22",
    "status_as_of": "2026-11-15",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/devices/avazzia-nuh",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "device": {
    "name": "Avazzia",
    "registry_name": "Avazzia",
    "url": "https://devicerts.com/devices/avazzia-nuh",
    "manufacturer": {
      "name": "Avazzia, Inc.",
      "url": "https://devicerts.com/manufacturers/avazzia-inc",
      "country": "United States",
      "country_basis": "FDA 510(k) applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K162392",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "NUH"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Avazzia is a neurology device classified under product code NUH. It is designed for use in neurological applications and has been determined to be substantially equivalent to predicate devices.\n\nThe device is supplied by Avazzia, Inc. located in Dallas, Texas. It received FDA 510(k) clearance with number K162392 on May 12, 2017, and was reviewed by the Neurology advisory committee. The device is intended for single-use or multiple-use applications, though specific sterility and MRI safety information are not provided in the data.",
      "ai_generated": true,
      "generated_on": "2026-09-22",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K162392",
      "number_label": null,
      "device_udi_di": null,
      "date": "2017-05-12",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K162392",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "NUH",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 882.5890",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Neurology",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}