{
  "format": "devicerts.device.v1",
  "cite_as": "WatchPAT ONE, Itamar Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/watchpat-one-mnr (data as of 2026-11-15).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/watchpat-one-mnr",
    "json_url": "https://devicerts.com/devices/watchpat-one-mnr.json",
    "markdown_url": "https://devicerts.com/devices/watchpat-one-mnr.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      },
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      }
    ],
    "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/watchpat-one-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": "WatchPAT ONE",
    "registry_name": "WatchPAT ONE",
    "url": "https://devicerts.com/devices/watchpat-one-mnr",
    "manufacturer": {
      "name": "Itamar Medical Ltd",
      "url": "https://devicerts.com/manufacturers/itamar-medical-ltd",
      "country": "Israel",
      "country_basis": null,
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "European Union and United States"
    },
    "classification": [
      {
        "class": "Class II",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "510(k) Number",
        "values": [
          {
            "value": "K183559",
            "registries": [
              "FDA 510(k)"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "MNR"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The WatchPAT ONE is a Ventilatory Effort Recorder, designed to monitor and record respiratory effort and apnea events during sleep. It employs peripheral arterial tone (PAT) technology to assess breathing patterns and detect obstructive sleep apnea (OSA) episodes by analyzing changes in blood volume in the finger.\n\nThis device is intended for single-use in clinical or home settings, supplied as a non-sterile, non-invasive system. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and EU MDR authorization. The device requires no special storage conditions and is compatible with MRI environments, though specific safety protocols should be followed.",
      "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."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "510(k)",
      "region": "United States",
      "type": "FDA 510(k)",
      "number": "K183559",
      "number_label": null,
      "device_udi_di": null,
      "date": "2019-06-05",
      "date_kind": "decision",
      "decision_code": "SESE",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    },
    {
      "registry": "EUDAMED",
      "region": "European Union",
      "type": "CE/MDR",
      "number": null,
      "number_label": null,
      "device_udi_di": null,
      "date": null,
      "date_kind": null,
      "decision_code": null,
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
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      "fields": [
        {
          "label": "510(k) Number",
          "values": [
            {
              "value": "K183559",
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            }
          ]
        },
        {
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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 868.2375",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Anesthesiology",
              "registries": [
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              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "SESE",
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            }
          ]
        }
      ]
    }
  ]
}