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FDA 510(k)

TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA

K-Number: K132544 · 2013-11-25

ApplicantTomtec Imaging Systems GmbH
Decision Date2013-11-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-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 2013-11-25 under 510(k) number K132544. 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 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA?

TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA is a medical device that received FDA 510(k) clearance on 2013-11-25. The listed applicant is Tomtec Imaging Systems GmbH. The 510(k) number is K132544.

When did TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA receive FDA 510(k) clearance?

TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA received FDA 510(k) clearance on 2013-11-25, under 510(k) number K132544.

Who is the listed applicant for TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-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 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA?

The FDA product code for TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA is LLZ.

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Other records listing Tomtec Imaging Systems GmbH as applicant

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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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