ROTEM sigma Thromboelastometry System— 510(k) K201440

Name: FDA 510(k) clearance K201440
Creator: U.S. Food and Drug Administration
Published: 2022-07-08

Substantially Equivalent

Tem Innovations GmbH

FDA 510(k) clearance K201440 for ROTEM sigma Thromboelastometry System, Substantially Equivalent on 2022-07-08. Applicant: Tem Innovations GmbH. Device class: 2.

Clearance details

Applicant: Tem Innovations GmbH
Product code: Code JPA
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 2020-06-01
Decision date: 2022-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

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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.