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FDA 510(k)

Zener® (model ZEN-001-B1)

K-Number: K252128 · 2025-09-15

ApplicantUvx, Inc.
Decision Date2025-09-15
Product CodeFRA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Zener® (model ZEN-001-B1) is a medical device manufactured by Uvx, Inc.. It received FDA 510(k) clearance on 2025-09-15 under approval number K252128. The device is classified under product code FRA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zener® (model ZEN-001-B1)?

Zener® (model ZEN-001-B1) is a medical device that received FDA 510(k) clearance on 2025-09-15. It is manufactured by Uvx, Inc.. The 510(k) number is K252128.

When was Zener® (model ZEN-001-B1) approved by the FDA?

Zener® (model ZEN-001-B1) received FDA 510(k) clearance on 2025-09-15, under approval number K252128.

What company makes Zener® (model ZEN-001-B1)?

Zener® (model ZEN-001-B1) is manufactured by Uvx, Inc..

What is the FDA product code for Zener® (model ZEN-001-B1)?

The FDA product code for Zener® (model ZEN-001-B1) is FRA.

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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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