# Watch-PAT200U Ventilatory Effort Recorder

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/watch-pat200u-mnr>
- Manufacturer: [Itamar Medical Ltd](https://devicerts.com/manufacturers/itamar-medical-ltd) (Israel)
- Name in the registry: Watch-PAT200U
- Device class: Class II (US FDA)
- FDA product code: MNR

## Overview

*AI-generated summary, 2026-09-20. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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).

The 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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K161579 · decision 2017-02-24 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K161579 [FDA 510(k)]
- FDA product code: MNR [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 868.2375 [FDA 510(k)]
- Advisory committee: Anesthesiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- 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).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-22
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/watch-pat200u-mnr.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). 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
- 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.