FDA 510(k)

ST-Z5

K-Number: K201878 · 2021-03-25

Decision Date2021-03-25

Product CodeKCT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ST-Z5 is a medical device manufactured by Z-Systems AG. It received FDA 510(k) clearance on 2021-03-25 under approval number K201878. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ST-Z5?

ST-Z5 is a medical device that received FDA 510(k) clearance on 2021-03-25. It is manufactured by Z-Systems AG. The 510(k) number is K201878.

When was ST-Z5 approved by the FDA?

ST-Z5 received FDA 510(k) clearance on 2021-03-25, under approval number K201878.

What company makes ST-Z5?

ST-Z5 is manufactured by Z-Systems AG.

What is the FDA product code for ST-Z5?

The FDA product code for ST-Z5 is KCT.

Other Devices by Z-Systems AG

K201712Z5-TL K200386Z5-BL K190243Z5-BL

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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.