WatchPAT400 (WP400)
K-Number: K250460 · 2025-09-05
Device Summary
Frequently Asked Questions
What is the WatchPAT400 (WP400)?
WatchPAT400 (WP400) is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Itamar Medical , Ltd.. The 510(k) number is K250460.
When did WatchPAT400 (WP400) receive FDA 510(k) clearance?
WatchPAT400 (WP400) received FDA 510(k) clearance on 2025-09-05, under 510(k) number K250460.
Who is the listed applicant for WatchPAT400 (WP400)?
The FDA 510(k) record lists Itamar Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for WatchPAT400 (WP400)?
The FDA product code for WatchPAT400 (WP400) is MNR.
Other records listing Itamar Medical , Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: MNR)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.