K-number	K232291
Device name	Essenz HLM, Essenz ILBM
Applicant	Livanova Deutschland, GmbH
Product code	DTQ
Device class	Class II
Decision date	Aug 24, 2023
Decision	Substantially Equivalent
Regulation	870.4220

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Source

View the full FDA submission: accessdata.fda.gov

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Essenz HLM, Essenz ILBM

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