FDA 510(k)

LVIS神經匹配

K 號：K222450 · 2023-06-09

決定日期2023-06-09

產品代碼OMB

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

LVIS NeuroMatch is the device name listed in this FDA 510(k) record. The listed applicant is LVIS Corporation. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K222450. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LVIS NeuroMatch?

LVIS NeuroMatch is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is LVIS Corporation. The 510(k) number is K222450.

When did LVIS NeuroMatch receive FDA 510(k) clearance?

LVIS NeuroMatch received FDA 510(k) clearance on 2023-06-09, under 510(k) number K222450.

Who is the listed applicant for LVIS NeuroMatch?

The FDA 510(k) record lists LVIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LVIS NeuroMatch?

The FDA product code for LVIS NeuroMatch is OMB.

其他以 LVIS Corporation 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。

K250239神經匹配 K241390神經匹配

相關器械（代碼：OMB）

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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