FDA 510(k)

Xeleris V 處理及評核系統

K 號：K221680 · 2023-03-01

決定日期2023-03-01

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

Xeleris V Processing and Review System is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K221680. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Xeleris V Processing and Review System?

Xeleris V Processing and Review System is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is GE Healthcare. The 510(k) number is K221680.

When did Xeleris V Processing and Review System receive FDA 510(k) clearance?

Xeleris V Processing and Review System received FDA 510(k) clearance on 2023-03-01, under 510(k) number K221680.

Who is the listed applicant for Xeleris V Processing and Review System?

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

What is the FDA product code for Xeleris V Processing and Review System?

The FDA product code for Xeleris V Processing and Review System is LLZ.

其他以 GE Healthcare 為申請人之記錄

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相關器械（代碼：LLZ）

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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