WatchPAT ONE (WP1)
K-Number: K223675 · 2023-01-06
ApplicantItamar Medical , Ltd.
Decision Date2023-01-06
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
WatchPAT ONE (WP1) is a medical device manufactured by Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2023-01-06 under approval number K223675. 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 WatchPAT ONE (WP1)?
WatchPAT ONE (WP1) is a medical device that received FDA 510(k) clearance on 2023-01-06. It is manufactured by Itamar Medical , Ltd.. The 510(k) number is K223675.
When was WatchPAT ONE (WP1) approved by the FDA?
WatchPAT ONE (WP1) received FDA 510(k) clearance on 2023-01-06, under approval number K223675.
What company makes WatchPAT ONE (WP1)?
WatchPAT ONE (WP1) is manufactured by Itamar Medical , Ltd..
What is the FDA product code for WatchPAT ONE (WP1)?
The FDA product code for WatchPAT ONE (WP1) 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.