ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)— 510(k) K222214
Substantially EquivalentThi 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. Device class: 2.
Clearance details
- Applicant
- Thi Total Healthcare Innovation GmbH
- Product code
- Code FXY
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Feistritz Im Rosental, AT
Recent devices under product code FXY
view all- K200493 — Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover
- K140588 — FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS
- K904969 — HOOD, OPERATING, SURGICAL
- K904276 — DISPOSABLE BEARD COVER
- K903533 — STERI-SHIELD
More clearances from Thi Total Healthcare Innovation GmbH
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