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510(k) K201440

ROTEM sigma Thromboelastometry System by Tem Innovations GmbH — Product Code JPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2022
Date Received
June 1, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Multipurpose For In Vitro Coagulation Studies
Device Class
Class II
Regulation Number
864.5425
Review Panel
HE
Submission Type

Other clearances by Tem Innovations GmbH

  • K101533 — EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM (August 10, 2011)

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