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ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222214
510(k) Type
Traditional
Applicant
THI Total Healthcare Innovation GmbH
Country
Austria
FDA Decision
Substantially Equivalent
Decision Date
10/17/2023
Days to Decision
449 days
Submission Type
Summary

ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222214
510(k) Type
Traditional
Applicant
THI Total Healthcare Innovation GmbH
Country
Austria
FDA Decision
Substantially Equivalent
Decision Date
10/17/2023
Days to Decision
449 days
Submission Type
Summary