FDA 510(k)

Z5-BL

K-Number: K200386 · 2020-10-14

Decision Date2020-10-14

Product CodeDZE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Z5-BL is the device name listed in this FDA 510(k) record. The listed applicant is Z-Systems AG. It received FDA 510(k) clearance on 2020-10-14 under 510(k) number K200386. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Z5-BL?

Z5-BL is a medical device that received FDA 510(k) clearance on 2020-10-14. The listed applicant is Z-Systems AG. The 510(k) number is K200386.

When did Z5-BL receive FDA 510(k) clearance?

Z5-BL received FDA 510(k) clearance on 2020-10-14, under 510(k) number K200386.

Who is the listed applicant for Z5-BL?

The FDA 510(k) record lists Z-Systems AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Z5-BL?

The FDA product code for Z5-BL is DZE.

Other records listing Z-Systems AG 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.

K201878ST-Z5 K201712Z5-TL 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.