K-number	K232789
Device name	VIO System (V-1000)
Applicant	Enspectra Health, Inc.
Product code	QZN
Device class	Class II
Decision date	Dec 22, 2023
Decision	Substantially Equivalent
Regulation	878.4580

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Source

View the full FDA submission: accessdata.fda.gov

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VIO System (V-1000)

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