ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)— 510(k) K222214

Substantially Equivalent

Thi Total Healthcare Innovation GmbH

FDA 510(k) clearance K222214 for ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood), Substantially Equivalent on 2023-10-17. Applicant: Thi Total Healthcare Innovation GmbH.

Clearance details

Applicant: Thi Total Healthcare Innovation GmbH
Product code: Code FXY
Advisory panel: General, Plastic Surgery
Date received: 2022-07-25
Decision date: 2023-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Feistritz Im Rosental, AT

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