WatchPAT400 (WP400)
K-Number: K250460 · 2025-09-05
ApplicantItamar Medical , Ltd.
Decision Date2025-09-05
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
WatchPAT400 (WP400) is a medical device manufactured by Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2025-09-05 under approval number K250460. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the WatchPAT400 (WP400)?
WatchPAT400 (WP400) is a medical device that received FDA 510(k) clearance on 2025-09-05. It is manufactured by Itamar Medical , Ltd.. The 510(k) number is K250460.
When was WatchPAT400 (WP400) approved by the FDA?
WatchPAT400 (WP400) received FDA 510(k) clearance on 2025-09-05, under approval number K250460.
What company makes WatchPAT400 (WP400)?
WatchPAT400 (WP400) is manufactured by Itamar Medical , Ltd..
What is the FDA product code for WatchPAT400 (WP400)?
The FDA product code for WatchPAT400 (WP400) is MNR.
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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.