FDA 510(k)

Voluson S6、Voluson S8、Voluson S8t、Voluson S10、Voluson S10 Expert

K 號：K213642 · 2022-01-13

決定日期2022-01-13

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2022-01-13 under 510(k) number K213642. 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 S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is a medical device that received FDA 510(k) clearance on 2022-01-13. The listed applicant is GE Healthcare. The 510(k) number is K213642.

When did Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert receive FDA 510(k) clearance?

Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert received FDA 510(k) clearance on 2022-01-13, under 510(k) number K213642.

Who is the listed applicant for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

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 S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert?

The FDA product code for Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert is IYN.

其他以 GE Healthcare 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。

K253639檢視設備名稱醫療設備規範文本檢視設備名稱醫療設備規範文本 K242925MR Contour DL K232346數位專家訪問搭配遠端掃描 K223212精準DL K221680Xeleris V 處理及評核系統 K221932Omni 神話

查看所有 55 項裝置 →

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。