FDA 510(k)

無菌導線確認

K 號：K191739 · 2020-01-02

決定日期2020-01-02

產品代碼GZL

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Sterile LeadConfirm is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Omega Engineering , Ltd.. It received FDA 510(k) clearance on 2020-01-02 under 510(k) number K191739. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sterile LeadConfirm?

Sterile LeadConfirm is a medical device that received FDA 510(k) clearance on 2020-01-02. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K191739.

When did Sterile LeadConfirm receive FDA 510(k) clearance?

Sterile LeadConfirm received FDA 510(k) clearance on 2020-01-02, under 510(k) number K191739.

Who is the listed applicant for Sterile LeadConfirm?

The FDA 510(k) record lists Alpha Omega Engineering , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile LeadConfirm?

The FDA product code for Sterile LeadConfirm is GZL.

其他以 Alpha Omega Engineering , 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。

K250601神經歐米茄系統；神經智慧系統 K220553神經歐米茄系統，神經智慧系統 K172042神經導航系統，神經智慧系統 K171581神經歐米茄系統

相關器械（代碼：GZL）

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。