FDA 510(k)

ViVi® 外科安全帽系統（ViVi® 安全帽、ViVi® 安全帽 HPL、ViVi® 頭罩）

K 號：K222214 · 2023-10-17

決定日期2023-10-17

產品代碼FXY

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) is the device name listed in this FDA 510(k) record. The listed applicant is Thi Total Healthcare Innovation GmbH. It received FDA 510(k) clearance on 2023-10-17 under 510(k) number K222214. The device is classified under product code FXY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)?

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) is a medical device that received FDA 510(k) clearance on 2023-10-17. The listed applicant is Thi Total Healthcare Innovation GmbH. The 510(k) number is K222214.

When did ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) receive FDA 510(k) clearance?

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) received FDA 510(k) clearance on 2023-10-17, under 510(k) number K222214.

Who is the listed applicant for ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)?

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

What is the FDA product code for ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)?

The FDA product code for ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) is FXY.

其他以 Thi Total Healthcare Innovation GmbH 為申請人之記錄

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K243522ViVi® Toga 預訂版

相關器械（代碼：FXY）

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。

K200493Stryker T7 外科帽，Stryker T7 外科袍，拉鍊式，Stryker T7 外科袍，拉鍊式可揭除臉盾，Stryker T7 外科袍，套頭式Stryker Corporation

官方來源

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