K-number	K210913
Device name	V12 PRO
Applicant	Slk Medical GmbH
Product code	IRP
Device class	Class II
Decision date	Aug 4, 2021
Decision	Substantially Equivalent
Regulation	890.5650

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Source

View the full FDA submission: accessdata.fda.gov

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V12 PRO

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