FDA 510(k)

Voluson E6, Voluson E8, Voluson E10

K 號：K162269 · 2016-10-03

決定日期2016-10-03

產品代碼IYN

諮詢委員會RA

決定Substantially Equivalent

器材摘要

Voluson E6, Voluson E8, Voluson E10 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2016-10-03 under 510(k) number K162269. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Voluson E6, Voluson E8, Voluson E10?

Voluson E6, Voluson E8, Voluson E10 is a medical device that received FDA 510(k) clearance on 2016-10-03. The listed applicant is GE Healthcare. The 510(k) number is K162269.

When did Voluson E6, Voluson E8, Voluson E10 receive FDA 510(k) clearance?

Voluson E6, Voluson E8, Voluson E10 received FDA 510(k) clearance on 2016-10-03, under 510(k) number K162269.

Who is the listed applicant for Voluson E6, Voluson E8, Voluson E10?

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 Voluson E6, Voluson E8, Voluson E10?

The FDA product code for Voluson E6, Voluson E8, Voluson E10 is IYN.

其他以 GE Healthcare 為申請人之記錄

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相關器械（代碼：IYN）

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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