K-number	K191384
Device name	RayCare 2.3
Applicant	RaySearch Laboratories AB (PUBL)
Product code	MUJ
Device class	Class II
Decision date	Jul 8, 2019
Decision	Substantially Equivalent
Regulation	892.5050

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Source

View the full FDA submission: accessdata.fda.gov

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RayCare 2.3

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