Name: Predicase
Price: 199 USD

K-number	K101533
Device name	EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
Applicant	Tem Innovations GmbH
Product code	JPA
Device class	Class II
Decision date	Aug 10, 2011
Decision	Substantially Equivalent
Regulation	864.5425

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Source

View the full FDA submission: accessdata.fda.gov

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EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM

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