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FDA 510(k)

ArgenZ MTZ

K-Number: K242458 · 2024-10-24

ApplicantArgen Corporation
Decision Date2024-10-24
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ArgenZ MTZ is a medical device manufactured by Argen Corporation. It received FDA 510(k) clearance on 2024-10-24 under approval number K242458. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArgenZ MTZ?

ArgenZ MTZ is a medical device that received FDA 510(k) clearance on 2024-10-24. It is manufactured by Argen Corporation. The 510(k) number is K242458.

When was ArgenZ MTZ approved by the FDA?

ArgenZ MTZ received FDA 510(k) clearance on 2024-10-24, under approval number K242458.

What company makes ArgenZ MTZ?

ArgenZ MTZ is manufactured by Argen Corporation.

What is the FDA product code for ArgenZ MTZ?

The FDA product code for ArgenZ MTZ is EIH.

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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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