FDA 510(k)

Apex 定位器 (FindPex)

K 號：K252224 · 2026-04-08

申請人Changzhou Sifary Medical Technology Co., Ltd.

決定日期2026-04-08

產品代碼LQY

決定相當於

器材摘要

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.

常見問題

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) 記錄將常州市思法瑞醫療科技有限公司列為申請人。這並不單獨確立設備製造商的身份。

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

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

其他以 Changzhou Sifary Medical 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。

K260795手持式牙科X光系統（HyperLight-M）K232068超輕便型X光機 K221152治療筆牙科固化燈 K201993E-connect S 結腸電動機，內建 Apex 定位器

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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