K-number	K191402
Device name	Heater-Cooler System 3T
Applicant	Livanova Deutschland, GmbH
Product code	DWC
Device class	Class II
Decision date	Feb 25, 2020
Decision	Substantially Equivalent
Regulation	870.4250

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View the full FDA submission: accessdata.fda.gov

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Heater-Cooler System 3T

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