WatchPAT200U (WP200U)
K-Number: K203839 · 2022-03-21
ApplicantItamar Medical , Ltd.
Decision Date2022-03-21
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
WatchPAT200U (WP200U) is a medical device manufactured by Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2022-03-21 under approval number K203839. 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 WatchPAT200U (WP200U)?
WatchPAT200U (WP200U) is a medical device that received FDA 510(k) clearance on 2022-03-21. It is manufactured by Itamar Medical , Ltd.. The 510(k) number is K203839.
When was WatchPAT200U (WP200U) approved by the FDA?
WatchPAT200U (WP200U) received FDA 510(k) clearance on 2022-03-21, under approval number K203839.
What company makes WatchPAT200U (WP200U)?
WatchPAT200U (WP200U) is manufactured by Itamar Medical , Ltd..
What is the FDA product code for WatchPAT200U (WP200U)?
The FDA product code for WatchPAT200U (WP200U) 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.