EndoPATx
K-Number: K211557 · 2022-12-29
ApplicantItamar Medical , Ltd.
Decision Date2022-12-29
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EndoPATx is a medical device manufactured by Itamar Medical , Ltd.. It received FDA 510(k) clearance on 2022-12-29 under approval number K211557. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EndoPATx?
EndoPATx is a medical device that received FDA 510(k) clearance on 2022-12-29. It is manufactured by Itamar Medical , Ltd.. The 510(k) number is K211557.
When was EndoPATx approved by the FDA?
EndoPATx received FDA 510(k) clearance on 2022-12-29, under approval number K211557.
What company makes EndoPATx?
EndoPATx is manufactured by Itamar Medical , Ltd..
What is the FDA product code for EndoPATx?
The FDA product code for EndoPATx is DQK.
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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.