K-number	K202369
Device name	RXS 1000
Applicant	Rolence Enterprise, Inc.
Product code	MUH
Device class	Class II
Decision date	Sep 15, 2021
Decision	Substantially Equivalent
Regulation	872.1800

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Source

View the full FDA submission: accessdata.fda.gov

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RXS 1000

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