Materialise Mimics Enlight
K-Number: K190874 · 2019-06-05
ApplicantMaterialise NV
Decision Date2019-06-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Materialise Mimics Enlight is a medical device manufactured by Materialise NV. It received FDA 510(k) clearance on 2019-06-05 under approval number K190874. 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 Materialise Mimics Enlight?
Materialise Mimics Enlight is a medical device that received FDA 510(k) clearance on 2019-06-05. It is manufactured by Materialise NV. The 510(k) number is K190874.
When was Materialise Mimics Enlight approved by the FDA?
Materialise Mimics Enlight received FDA 510(k) clearance on 2019-06-05, under approval number K190874.
What company makes Materialise Mimics Enlight?
Materialise Mimics Enlight is manufactured by Materialise NV.
What is the FDA product code for Materialise Mimics Enlight?
The FDA product code for Materialise Mimics Enlight is LLZ.
Other Devices by Materialise NV
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.