K-number	K213942
Device name	Esteya
Applicant	Nucletron B.V.
Product code	JAD
Device class	Class II
Decision date	Jan 11, 2022
Decision	Substantially Equivalent
Regulation	892.5900

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Source

View the full FDA submission: accessdata.fda.gov

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Esteya

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