Identifiers
- 510(k) Number
- K081037 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 device is a Ventilatory Effort Recorder, as defined in the openFDA data. It is used to record ventilatory effort, which involves monitoring respiratory effort during clinical assessment.
It is supplied by Itamar Medical and has received FDA 510(k) clearance under k-number K081037. The device is classified as a Class II medical device with product code MNR and regulation number 868.2375, and is intended for use in anesthesiology settings.
Frequently asked questions
What is the WATCH-PAT 200I (WP200I) used for?
The WATCH-PAT 200I (WP200I) is a Ventilatory Effort Recorder designed to record ventilatory effort by monitoring respiratory effort during clinical assessment, specifically intended for use in anesthesiology settings as indicated in its FDA 510(k) submission.
How is the WATCH-PAT 200I (WP200I) supplied and who manufactures it?
The device is supplied by Itamar Medical, the manufacturer listed in the FDA 510(k) clearance documentation, and is identified as the WATCH-PAT 200I (WP200I) model under the applicant name Itamar Medical.
What regulatory pathway and classification apply to the WATCH-PAT 200I (WP200I)?
The WATCH-PAT 200I (WP200I) received FDA 510(k) clearance under k-number K081037, is classified as a Class II medical device with product code MNR, and is subject to regulation number 868.2375, with a special clearance type and substantially equivalent decision.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081037 | Class II | Active |
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Manufacturer
- Manufacturer
- Itamar Medical
Sources (1)
- FDA 510(k) K081037 24 fields · synced Sep 23, 2026