FDA 510(k)

Apex定位器（FindPex）

K号: K252224 · 2026-04-08

申请人Changzhou Sifary Medical Technology Co., Ltd.

决定日期2026-04-08

产品代码LQY

决定实质等同

器械摘要

Apex Locator (FindPex) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-08 under 510(k) number K252224. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

常见问题

What is the Apex Locator (FindPex)?

Apex Locator (FindPex) is a medical device that received FDA 510(k) clearance on 2026-04-08. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K252224.

When did Apex Locator (FindPex) receive FDA 510(k) clearance?

Apex Locator (FindPex) received FDA 510(k) clearance on 2026-04-08, under 510(k) number K252224.

Who is the listed applicant for Apex Locator (FindPex)?

FDA 510(k)记录将常州思法瑞医疗科技有限公司列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Apex Locator (FindPex)?

The FDA product code for Apex Locator (FindPex) is LQY.

列明Changzhou Sifary Medical Technology Co., Ltd.为申报人的其他记录

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。

K260795手持式牙科X射线系统（HyperLight-M）K232068HyperLight 便携式X射线单元 K221152CuringPen Dental Curing Light K201993E-connect S Endo Motor with built-in Apex Locator

官方来源

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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。