FDA 510(k)

ViVi® 수술용 헬멧 시스템 (ViVi® 헬멧, ViVi® 헬멧 HPL, ViVi® 히트)

K-번호: K222214 · 2023-10-17

결정일2023-10-17

제품 코드FXY

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Thi Total Healthcare Innovation GmbH를 신청인으로 등재한 기타 기록

K243522ViVi® Toga 프리미엄

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