TOMTEC-ARENA
K-Number: K201632 · 2020-08-14
ApplicantTomtec Imaging Systems GmbH
Decision Date2020-08-14
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
TOMTEC-ARENA is a medical device manufactured by Tomtec Imaging Systems GmbH. It received FDA 510(k) clearance on 2020-08-14 under approval number K201632. 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 TOMTEC-ARENA?
TOMTEC-ARENA is a medical device that received FDA 510(k) clearance on 2020-08-14. It is manufactured by Tomtec Imaging Systems GmbH. The 510(k) number is K201632.
When was TOMTEC-ARENA approved by the FDA?
TOMTEC-ARENA received FDA 510(k) clearance on 2020-08-14, under approval number K201632.
What company makes TOMTEC-ARENA?
TOMTEC-ARENA is manufactured by Tomtec Imaging Systems GmbH.
What is the FDA product code for TOMTEC-ARENA?
The FDA product code for TOMTEC-ARENA is LLZ.
Other Devices by Tomtec Imaging Systems GmbH
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.