免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料,僅供一般參考,不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

Apex 定位器 (AL-Pex), Apex 定位器 (AL-Pex+)

K 號:K232717 · 2023-12-22

決定日期2023-12-22
產品代碼LQY
決定相當於

器材摘要

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Haili Medical Co., Ltd.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K232717. The device is classified under product code LQY. FDA Decision: Substantially Equivalent.

常見問題

What is the Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Changzhou Haili Medical Co., Ltd.. The 510(k) number is K232717.

When did Apex Locator (AL-Pex), Apex Locator (AL-Pex+) receive FDA 510(k) clearance?

Apex Locator (AL-Pex), Apex Locator (AL-Pex+) received FDA 510(k) clearance on 2023-12-22, under 510(k) number K232717.

Who is the listed applicant for Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?

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

What is the FDA product code for Apex Locator (AL-Pex), Apex Locator (AL-Pex+)?

The FDA product code for Apex Locator (AL-Pex), Apex Locator (AL-Pex+) is LQY.

相關臨床試驗

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。

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊,請始終參閱官方記錄。

↑