{
  "format": "devicerts.device.v1",
  "cite_as": "EasyOne Pro Respiratory Testing Device, Ndd Medizitechnik AG. deviCERTS medical device catalogue. https://devicerts.com/devices/easyone-pro-respiratory-testing-device-bty (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/easyone-pro-respiratory-testing-device-bty",
    "json_url": "https://devicerts.com/devices/easyone-pro-respiratory-testing-device-bty.json",
    "markdown_url": "https://devicerts.com/devices/easyone-pro-respiratory-testing-device-bty.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
    ],
    "registry_records_last_synced": "2026-10-06",
    "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/easyone-pro-respiratory-testing-device-bty",
    "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": "EasyOne Pro Respiratory Testing Device",
    "registry_name": "EASYONE PRO RESPIRATORY TESTING DEVICE",
    "url": "https://devicerts.com/devices/easyone-pro-respiratory-testing-device-bty",
    "manufacturer": {
      "name": "Ndd Medizitechnik AG",
      "url": "https://devicerts.com/manufacturers/ndd-medizitechnik-ag",
      "country": null,
      "country_basis": null,
      "fda_registration_country": "United States"
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K120635",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "BTY"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The EasyOne Pro Respiratory Testing Device is a portable pulmonary function testing machine classified as a Calculator, Predicted Values, Pulmonary Function device under FDA regulation 868.1890. It performs spirometry, single-breath carbon monoxide diffusion (DLCO) testing, and multiple-breath nitrogen washout assessments to evaluate lung function parameters such as airflow, lung volumes, and gas exchange efficiency.\n\nThis device is intended for use in clinical settings, including general practice, clinics, and hospitals, and is designed for point-of-care diagnostics. Supplied as a reusable medical instrument, it requires proper calibration and maintenance to ensure accurate results. Authorized under FDA 510(k) clearance (K120635) with a traditional review process, it adheres to regulatory standards for respiratory diagnostic equipment. No specific sterility claims are stated, but standard infection control protocols apply for reusable devices.",
      "ai_generated": true,
      "generated_on": "2026-09-19",
      "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": "K120635",
      "number_label": null,
      "device_udi_di": null,
      "date": "2012-09-27",
      "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": "K120635",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "BTY",
              "registries": [
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            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class II",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 868.1890",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Anesthesiology",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
              "registries": [
                "FDA 510(k)"
              ]
            }
          ]
        }
      ]
    }
  ]
}