FDA 510(k)

XC11 冰冻系统，美国

K号: K250955 · 2025-10-22

决定日期2025-10-22

产品代码OBJ

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

XC11 ICE System, USA is the device name listed in this FDA 510(k) record. The listed applicant is Yorlabs, Inc.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K250955. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XC11 ICE System, USA?

XC11 ICE System, USA is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Yorlabs, Inc.. The 510(k) number is K250955.

When did XC11 ICE System, USA receive FDA 510(k) clearance?

XC11 ICE System, USA received FDA 510(k) clearance on 2025-10-22, under 510(k) number K250955.

Who is the listed applicant for XC11 ICE System, USA?

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

What is the FDA product code for XC11 ICE System, USA?

The FDA product code for XC11 ICE System, USA is OBJ.

相关器械（代码：OBJ）

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器械摘要

常见问题

相关临床试验

相关器械（代码：OBJ）

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