K-number	K201440
Device name	ROTEM sigma Thromboelastometry System
Applicant	Tem Innovations GmbH
Product code	JPA
Device class	Class II
Decision date	Jul 8, 2022
Decision	Substantially Equivalent
Regulation	864.5425

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View the full FDA submission: accessdata.fda.gov

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ROTEM sigma Thromboelastometry System

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