K-number	K231287
Device name	POTENZA
Applicant	Jeisys Medical, Inc.
Product code	GEI
Device class	Class II
Decision date	Nov 5, 2024
Decision	Substantially Equivalent
Regulation	878.4400

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Source

View the full FDA submission: accessdata.fda.gov

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POTENZA

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