FDA 510(k)

ViVi®手術ヘルメットシステム（ViVi®ヘルメット、ViVi®ヘルメットHPL、ViVi®ハood）

K番号: K222214 · 2023-10-17

決定日2023-10-17

製品コードFXY

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてThi Total Healthcare Innovation GmbHを記載するその他の記録

K243522ViVi® Toga プレミアム

公式ソース

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