FDA 510(k)

Optima XR240amx

K 號：K162990 · 2016-11-15

決定日期2016-11-15

產品代碼IZL

諮詢委員會RA

決定Substantially Equivalent

器材摘要

Optima XR240amx is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-11-15 under 510(k) number K162990. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optima XR240amx?

Optima XR240amx is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K162990.

When did Optima XR240amx receive FDA 510(k) clearance?

Optima XR240amx received FDA 510(k) clearance on 2016-11-15, under 510(k) number K162990.

Who is the listed applicant for Optima XR240amx?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Optima XR240amx?

The FDA product code for Optima XR240amx is IZL.

其他以 Ge Medical Systems, LLC 為申請人之記錄

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相關器械（代碼：IZL）

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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