ROTEM Sigma Thromboelastometry System

System, Multipurpose For In Vitro Coagulation Studies

Tem Innovations GmbH

The following data is part of a premarket notification filed by Tem Innovations Gmbh with the FDA for Rotem Sigma Thromboelastometry System.

Pre-market Notification Details

Device IDK201440
510k NumberK201440
Device Name:ROTEM Sigma Thromboelastometry System
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant Tem Innovations GmbH Martin-Kollar-Strasse 15 Munich,  DE 81829
ContactDavid Jacob
CorrespondentDavid Jacob
Tem Innovations GmbH Martin-Kollar-Strasse 15 Munich,  DE 81829
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-01
Decision Date2022-07-08

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