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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, multipurpose for in vitro coagulation studies
510(k) Number K201440
Device Name ROTEM sigma Thromboelastometry System
Applicant
Tem Innovations GmbH
Martin-Kollar-Strasse 15
Munich,  DE 81829
Applicant Contact David Jacob
Correspondent
Tem Innovations GmbH
Martin-Kollar-Strasse 15
Munich,  DE 81829
Correspondent Contact David Jacob
Regulation Number864.5425
Classification Product Code
JPA  
Date Received06/01/2020
Decision Date 07/08/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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