K222214
- 510(k) number
- K222214
- Device name
- ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
- Applicant
- Thi Total Healthcare Innovation GmbH AT
- Product code
- FXY — Hood, Surgical
- Decision date
- 2023-10-17
- Date received
- 2022-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K222214.pdf
Official FDA record: K222214
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.