K-number	K202221
Device name	VX650
Applicant	Luneau Technology Operations
Product code	HKI
Device class	Class II
Decision date	Jan 29, 2021
Decision	Substantially Equivalent
Regulation	886.1120

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Source

View the full FDA submission: accessdata.fda.gov

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VX650

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