K-number	K190966
Device name	Katalyst Training System
Applicant	Katalyst, Inc.
Product code	NGX
Device class	Class II
Decision date	Feb 3, 2020
Decision	Substantially Equivalent
Regulation	890.5850

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Source

View the full FDA submission: accessdata.fda.gov

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Katalyst Training System

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