K-number	K203579
Device name	Infinity Gateway Suite
Applicant	Draeger Medical Systems, Inc.
Product code	MSX
Device class	Class II
Decision date	Jun 7, 2022
Decision	Substantially Equivalent
Regulation	870.2300

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Source

View the full FDA submission: accessdata.fda.gov

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Infinity Gateway Suite

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