FDA 510(k)

神經歐米茄系統；神經智慧系統

K 號：K250601 · 2025-03-30

決定日期2025-03-30

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

Neuro Omega System; NeuroSmart System 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 2025-03-30 under 510(k) number K250601. 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 Neuro Omega System; NeuroSmart System?

Neuro Omega System; NeuroSmart System is a medical device that received FDA 510(k) clearance on 2025-03-30. The listed applicant is Alpha Omega Engineering , Ltd.. The 510(k) number is K250601.

When did Neuro Omega System; NeuroSmart System receive FDA 510(k) clearance?

Neuro Omega System; NeuroSmart System received FDA 510(k) clearance on 2025-03-30, under 510(k) number K250601.

Who is the listed applicant for Neuro Omega System; NeuroSmart System?

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 Neuro Omega System; NeuroSmart System?

The FDA product code for Neuro Omega System; NeuroSmart System 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。

K220553神經歐米茄系統，神經智慧系統 K191739無菌導線確認 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。