510(k) K101533— EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM

Substantially Equivalent

Tem Innovations GmbH

Clearance details

Applicant: Tem Innovations GmbH
Product code: Code JPA
Advisory panel: Hematology
Date received: 2010-06-03
Decision date: 2011-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, Bavaria/Upper Bavaria, DE

Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.