{
  "format": "devicerts.device.v1",
  "cite_as": "Watch-PAT200U Ventilatory Effort Recorder, Itamar Medical Ltd. deviCERTS medical device catalogue. https://devicerts.com/devices/watch-pat200u-mnr (data as of 2026-11-15).",
  "source": {
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    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA 510(k)",
        "url": "https://open.fda.gov/apis/device/510k/"
      }
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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/watch-pat200u-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": "Watch-PAT200U Ventilatory Effort Recorder",
    "registry_name": "Watch-PAT200U",
    "url": "https://devicerts.com/devices/watch-pat200u-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": "United States"
    },
    "classification": [
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        "class": "Class II",
        "system": "US FDA"
      }
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        "values": [
          {
            "value": "K161579",
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        ]
      }
    ],
    "product_codes": [
      "MNR"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "The Watch-PAT200U is a ventilatory effort recorder, designed to monitor respiratory effort and sleep-related breathing patterns. It utilises patented technology to detect apnoeas, hypopnoeas, and other respiratory events by measuring changes in peripheral arterial tone and body position. This non-invasive device is primarily used in the assessment of sleep-disordered breathing, including obstructive sleep apnoea (OSA).\n\nThe Watch-PAT200U is supplied as a reusable medical device and is intended for use in clinical settings such as sleep laboratories or home monitoring environments. It operates without the need for MRI compatibility and is classified as a Class II device under FDA regulations. The device requires calibration and maintenance as specified in its operational manuals. Authorisation for this device includes an FDA 510(k) clearance under the advisory committee for Anesthesiology, with a decision date of February 24, 2017.",
      "ai_generated": true,
      "generated_on": "2026-09-20",
      "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": "K161579",
      "number_label": null,
      "device_udi_di": null,
      "date": "2017-02-24",
      "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": [
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          "label": "510(k) Number",
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        {
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}