WatchPAT ONE
K-Number: K183559 · 2019-06-05
ApplicantItamar Medical , Ltd.
Decision Date2019-06-05
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
WatchPAT ONE is a medical device manufactured by Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2019-06-05 under approval number K183559. 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?
WatchPAT ONE is a medical device that received FDA 510(k) clearance on 2019-06-05. It is manufactured by Itamar Medical , Ltd.. The 510(k) number is K183559.
When was WatchPAT ONE approved by the FDA?
WatchPAT ONE received FDA 510(k) clearance on 2019-06-05, under approval number K183559.
What company makes WatchPAT ONE?
WatchPAT ONE is manufactured by Itamar Medical , Ltd..
What is the FDA product code for WatchPAT ONE?
The FDA product code for WatchPAT ONE 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.