{
  "format": "devicerts.device.v1",
  "cite_as": "WatchPAT300 (WP300), Itamar Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/watchpat300-wp300-mnr (data as of 2026-11-15).",
  "source": {
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    "markdown_url": "https://devicerts.com/devices/watchpat300-wp300-mnr.md",
    "publisher": "deviCERTS (devicerts.com)",
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      {
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      {
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        "url": "https://ec.europa.eu/tools/eudamed"
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    "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/watchpat300-wp300-mnr",
    "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": "WatchPAT300 (WP300)",
    "registry_name": "WatchPAT300 (WP300)",
    "url": "https://devicerts.com/devices/watchpat300-wp300-mnr",
    "manufacturer": {
      "name": "Itamar Medical Ltd",
      "url": "https://devicerts.com/manufacturers/itamar-medical-ltd",
      "country": "Israel",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
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      "label": "Active",
      "detail": "European Union and United States"
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        "system": "US FDA"
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        ]
      }
    ],
    "product_codes": [
      "MNR"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The WatchPAT300 (WP300) is a Ventilatory Effort Recorder, designed to monitor respiratory effort and peripheral arterial tonometry signals for sleep-related breathing disorders. It provides non-invasive assessment of sleep apnea by detecting changes in blood flow and respiratory patterns without requiring traditional airflow-based measurements.\n\nThis device is intended for use in clinical and home settings to aid in diagnosing sleep apnea. Supplied as a reusable medical instrument, it does not require sterilisation and is classified as a Class II device under FDA regulations. The WatchPAT300 operates in accordance with FDA 510(k) clearance and EU MDR compliance, with no specific MRI safety restrictions stated. It is authorised for use in anaesthesiology and requires proper storage as per manufacturer guidelines.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
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  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K222331",
      "number_label": null,
      "device_udi_di": null,
      "date": "2022-09-14",
      "date_kind": "decision",
      "decision_code": "SESE",
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      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
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      "region": "European Union",
      "type": "CE/MDR",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
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      "decision_code": null,
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    }
  ],
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  "certificates": [],
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    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
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            {
              "value": "Class II",
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            }
          ]
        },
        {
          "label": "Regulation",
          "values": [
            {
              "value": "21 CFR Part 868.2375",
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            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Anesthesiology",
              "registries": [
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              ]
            }
          ]
        },
        {
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}