K-number	K203790
Device name	GEM Premier 5000
Applicant	Instrumentation Laboratory CO
Product code	CHL
Device class	Class II
Decision date	Aug 20, 2021
Decision	Substantially Equivalent
Regulation	862.1120

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Source

View the full FDA submission: accessdata.fda.gov

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GEM Premier 5000

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