Zener®（型号 ZEN-001-B1）
K号: K252128 · 2025-09-15
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申请人Uvx, Inc.
决定日期2025-09-15
产品代码FRA
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：FRA）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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