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Watch-PAT 200S-2 (WP200S-2)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081982

by Itamar Medical

Identifiers

510(k) Number
K081982 FDA 510(k)
FDA Product Code
MNR FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.2375 FDA 510(k)
Regulation Number
868.2375 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Watch-PAT 200S-2 (WP200S-2) is a Ventilatory Effort Recorder, as defined in the device data. It is a portable home sleep apnea test and diagnostic device used for the detection of sleep apnea.

The device is supplied for use in home and ambulatory settings, as indicated by its description as a home sleep study device. It has received FDA 510(k) clearance (K081982) and is classified as a Class II device under regulation number 868.2375, with product code MNR. The device is intended for use with patients suspected to have sleep-related breathing disorders.

Frequently asked questions

What is the Watch-PAT 200S-2 used for?

The Watch-PAT 200S-2 is used for the detection of sleep apnea in patients suspected to have sleep-related breathing disorders. It functions as a portable home sleep apnea test and diagnostic device, recording ventilatory effort to assess breathing patterns during sleep in home or ambulatory environments.

How is the Watch-PAT 200S-2 supplied and where is it intended for use?

The device is supplied for use in home and ambulatory settings, as indicated by its description as a home sleep study device. It is designed for portable use outside clinical facilities, allowing patients to undergo sleep testing in their own homes under appropriate guidance.

What regulatory pathway was used for the Watch-PAT 200S-2 and what is its classification?

The Watch-PAT 200S-2 received FDA 510(k) clearance under submission K081982 and is classified as a Class II medical device under regulation number 868.2375 with product code MNR. This classification reflects its risk level and the regulatory controls required for safety and effectiveness.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Watchpat - Home Sleep Study Device - ZOLL Itamar - Itamar Medical, ITAMAR MEDICAL WATCHPAT 200 OPERATION MANUAL Pdf Download, PDF Watch-PAT200 - SleepWorks Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Itamar Medical

Sources (1)

  • FDA 510(k) K081982 24 fields · synced Sep 28, 2026