FDA 510(k)

Apex 定位器

K 號：K242383 · 2025-03-07

決定日期2025-03-07

產品代碼LQY

決定相當於

器材摘要

Apex Locator is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Rogin Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-03-07 under 510(k) number K242383. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

常見問題

What is the Apex Locator?

Apex Locator is a medical device that received FDA 510(k) clearance on 2025-03-07. The listed applicant is Shenzhen Rogin Medical Co., Ltd.. The 510(k) number is K242383.

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

Apex Locator received FDA 510(k) clearance on 2025-03-07, under 510(k) number K242383.

Who is the listed applicant for Apex Locator?

The FDA 510(k) record lists Shenzhen Rogin Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Apex Locator?

The FDA product code for Apex Locator is LQY.

其他以 Shenzhen Rogin Medical Co., Ltd. 為申請人之記錄

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K242514Endo 電機 (E-LITE MAX, E-LITE PRO, E-LITE INO)

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。

K252224Apex 定位器 (FindPex)Changzhou Sifary Medical Technology Co., Ltd.K242765電子尖峰定位器（Alpha Apex I）SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K231990Apex 定位器Cefla S.C.K232717Apex 定位器 (AL-Pex), Apex 定位器 (AL-Pex+)Changzhou Haili Medical Co., Ltd.K212178根端定位器Foshan Coxo Medical Instrument Co., Ltd.K210789EQ-PEXMeta Systems Co., Ltd.

官方來源

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