WatchPAT400 (WP400)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K250460

Identifiers

510(k) Number: K250460 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 WatchPAT400 (WP400) is a Ventilatory Effort Recorder, designed to monitor breathing patterns and effort during sleep. It provides continuous, non-invasive assessment of respiratory events, including apneas and hypopneas, by combining oximetry and actigraphy data to evaluate sleep-disordered breathing.

This device is intended for use in clinical and home settings to evaluate ventilatory effort and breathing frequency. Supplied as a reusable medical device, it operates on 1.5V DC and meets IP22 protection standards. Authorized under FDA 510(k) and MDR, the WatchPAT400 (WP400) is classified as a Class II device under regulation 21 CFR 868.2375 and product code MNR. It requires proper calibration and maintenance as specified in manufacturer instructions.

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: ZOLL ITAMAR WATCHPAT 400 OPERATION MANUAL Pdf Download, PDF 1.5V DC IP22 only IC: 27705-WATCHPATONE HVIN: WatchPAT ONE, WatchPAT400 (WP400) (K250460) — FDA 510 (k) | Innolitics

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K250460	Class II	Active

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Manufacturer

Manufacturer: Itamar Medical Ltd
FDA Applicant: Itamar Medical , Ltd.

Sources (2)

FDA 510(k) K250460 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 18, 2026