Name: Predicase
Price: 199 USD

K-number	K222214
Device name	ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
Applicant	Thi Total Healthcare Innovation GmbH
Product code	FXY
Device class	Class II
Decision date	Oct 17, 2023
Decision	Substantially Equivalent
Regulation	878.4040

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.