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FDA 510(k)

TOMTEC-ARENA

K-Number: K213544 · 2022-01-06

ApplicantTomtec Imaging Systems GmbH
Decision Date2022-01-06
Product CodeQIH
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 2022-01-06 under approval number K213544. The device is classified under product code QIH. 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 2022-01-06. It is manufactured by Tomtec Imaging Systems GmbH. The 510(k) number is K213544.

When was TOMTEC-ARENA approved by the FDA?

TOMTEC-ARENA received FDA 510(k) clearance on 2022-01-06, under approval number K213544.

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 QIH.

Other Devices by Tomtec Imaging Systems GmbH

K201632TOMTEC-ARENA

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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.

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