K-number	K210077
Device name	MED RF 4000
Applicant	F Care Systems USA, LLC
Product code	ONQ
Device class	Class II
Decision date	Dec 17, 2021
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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MED RF 4000

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