FDA 510(k)

电子尖端定位器（Alpha Apex I）

K号: K242765 · 2025-01-17

申请人SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

决定日期2025-01-17

产品代码LQY

决定实质等同

器械摘要

Electronic Apex Locator (Alpha Apex I) is the device name listed in this FDA 510(k) record. The listed applicant is SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K242765. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

常见问题

What is the Electronic Apex Locator (Alpha Apex I)?

Electronic Apex Locator (Alpha Apex I) is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. The 510(k) number is K242765.

When did Electronic Apex Locator (Alpha Apex I) receive FDA 510(k) clearance?

Electronic Apex Locator (Alpha Apex I) received FDA 510(k) clearance on 2025-01-17, under 510(k) number K242765.

Who is the listed applicant for Electronic Apex Locator (Alpha Apex I)?

The FDA 510(k) record lists SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Apex Locator (Alpha Apex I)?

The FDA product code for Electronic Apex Locator (Alpha Apex I) is LQY.

列明SHENZHEN SUPERLINE 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。

K252223Alpha Endo手柄（Alpha Endo）

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