K-number	K220396
Device name	EasyStat 300
Applicant	Medica Corporation
Product code	CEM
Device class	Class II
Decision date	Sep 26, 2023
Decision	Substantially Equivalent
Regulation	862.1600

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Source

View the full FDA submission: accessdata.fda.gov

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EasyStat 300

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