K-number	K202154
Device name	B-Capta
Applicant	Livanova Deutschland, GmbH
Product code	DRY
Device class	Class II
Decision date	Apr 1, 2021
Decision	Substantially Equivalent
Regulation	870.4330

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Source

View the full FDA submission: accessdata.fda.gov

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B-Capta

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