WatchPAT300 (WP300)
K-Number: K222331 · 2022-09-14
ApplicantItamar Medical , Ltd.
Decision Date2022-09-14
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
WatchPAT300 (WP300) is a medical device manufactured by Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2022-09-14 under approval number K222331. 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 WatchPAT300 (WP300)?
WatchPAT300 (WP300) is a medical device that received FDA 510(k) clearance on 2022-09-14. It is manufactured by Itamar Medical , Ltd.. The 510(k) number is K222331.
When was WatchPAT300 (WP300) approved by the FDA?
WatchPAT300 (WP300) received FDA 510(k) clearance on 2022-09-14, under approval number K222331.
What company makes WatchPAT300 (WP300)?
WatchPAT300 (WP300) is manufactured by Itamar Medical , Ltd..
What is the FDA product code for WatchPAT300 (WP300)?
The FDA product code for WatchPAT300 (WP300) 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.