FDA 510(k)

Zener®（型號 ZEN-001-B1）

K 號：K252128 · 2025-09-15

決定日期2025-09-15

產品代碼FRA

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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

常見問題

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. The listed applicant is Uvx, Inc.. The 510(k) number is K252128.

When did Zener® (model ZEN-001-B1) receive FDA 510(k) clearance?

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

Who is the listed applicant for Zener® (model ZEN-001-B1)?

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

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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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：FRA）

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