FDA 510(k)

TOMTEC-ARENA

K-Number: K213544 · 2022-01-06

Decision Date2022-01-06

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TOMTEC-ARENA is the device name listed in this FDA 510(k) record. The listed applicant is Tomtec Imaging Systems GmbH. It received FDA 510(k) clearance on 2022-01-06 under 510(k) 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. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K213544.

When did TOMTEC-ARENA receive FDA 510(k) clearance?

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

Who is the listed applicant for TOMTEC-ARENA?

The FDA 510(k) record lists Tomtec Imaging Systems GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOMTEC-ARENA?

The FDA product code for TOMTEC-ARENA is QIH.

Other records listing Tomtec Imaging Systems GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201632TOMTEC-ARENA

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.