FDA 510(k)

Voluson P6, Voluson P8

K 號：K213689 · 2022-02-17

決定日期2022-02-17

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Voluson P6, Voluson P8 is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K213689. 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 P6, Voluson P8?

Voluson P6, Voluson P8 is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is GE Healthcare. The 510(k) number is K213689.

When did Voluson P6, Voluson P8 receive FDA 510(k) clearance?

Voluson P6, Voluson P8 received FDA 510(k) clearance on 2022-02-17, under 510(k) number K213689.

Who is the listed applicant for Voluson P6, Voluson P8?

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 P6, Voluson P8?

The FDA product code for Voluson P6, Voluson P8 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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