FDA 510(k)

電子尖峰定位器（Alpha Apex I）

K 號：K242765 · 2025-01-17

申請人SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.

決定日期2025-01-17

產品代碼LQY

決定相當於

器材摘要

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.

常見問題

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.

其他以 SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：LQY）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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