Artemis
K-Number: K162474 · 2016-10-21
ApplicantEigen
Decision Date2016-10-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Artemis is a medical device manufactured by Eigen. It received FDA 510(k) clearance on 2016-10-21 under approval number K162474. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Artemis?
Artemis is a medical device that received FDA 510(k) clearance on 2016-10-21. It is manufactured by Eigen. The 510(k) number is K162474.
When was Artemis approved by the FDA?
Artemis received FDA 510(k) clearance on 2016-10-21, under approval number K162474.
What company makes Artemis?
Artemis is manufactured by Eigen.
What is the FDA product code for Artemis?
The FDA product code for Artemis is LLZ.
Other Devices by Eigen
Related Devices (Code: LLZ)
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.