Artemis, Artemis TPO, Artemis MX
K-Number: K222222 · 2023-10-12
ApplicantEigen
Decision Date2023-10-12
Product CodeQTZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Artemis, Artemis TPO, Artemis MX is a medical device manufactured by Eigen. It received FDA 510(k) clearance on 2023-10-12 under approval number K222222. The device is classified under product code QTZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Artemis, Artemis TPO, Artemis MX?
Artemis, Artemis TPO, Artemis MX is a medical device that received FDA 510(k) clearance on 2023-10-12. It is manufactured by Eigen. The 510(k) number is K222222.
When was Artemis, Artemis TPO, Artemis MX approved by the FDA?
Artemis, Artemis TPO, Artemis MX received FDA 510(k) clearance on 2023-10-12, under approval number K222222.
What company makes Artemis, Artemis TPO, Artemis MX?
Artemis, Artemis TPO, Artemis MX is manufactured by Eigen.
What is the FDA product code for Artemis, Artemis TPO, Artemis MX?
The FDA product code for Artemis, Artemis TPO, Artemis MX is QTZ.
Other Devices by Eigen
Related Devices (Code: QTZ)
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.