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FDA 510(k)

ZURA TEE SYSTEM

K-Number: K080223 · 2008-06-24

ApplicantImacor, LLC
Decision Date2008-06-24
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ZURA TEE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Imacor, LLC. It received FDA 510(k) clearance on 2008-06-24 under 510(k) number K080223. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZURA TEE SYSTEM?

ZURA TEE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-24. The listed applicant is Imacor, LLC. The 510(k) number is K080223.

When did ZURA TEE SYSTEM receive FDA 510(k) clearance?

ZURA TEE SYSTEM received FDA 510(k) clearance on 2008-06-24, under 510(k) number K080223.

Who is the listed applicant for ZURA TEE SYSTEM?

The FDA 510(k) record lists Imacor, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZURA TEE SYSTEM?

The FDA product code for ZURA TEE SYSTEM is IYO.

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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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