Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ROTEM sigma Thromboelastometry System

K-Number: K201440 · 2022-07-08

ApplicantTem Innovations GmbH
Decision Date2022-07-08
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ROTEM sigma Thromboelastometry System is a medical device manufactured by Tem Innovations GmbH. It received FDA 510(k) clearance on 2022-07-08 under approval number K201440. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTEM sigma Thromboelastometry System?

ROTEM sigma Thromboelastometry System is a medical device that received FDA 510(k) clearance on 2022-07-08. It is manufactured by Tem Innovations GmbH. The 510(k) number is K201440.

When was ROTEM sigma Thromboelastometry System approved by the FDA?

ROTEM sigma Thromboelastometry System received FDA 510(k) clearance on 2022-07-08, under approval number K201440.

What company makes ROTEM sigma Thromboelastometry System?

ROTEM sigma Thromboelastometry System is manufactured by Tem Innovations GmbH.

What is the FDA product code for ROTEM sigma Thromboelastometry System?

The FDA product code for ROTEM sigma Thromboelastometry System is JPA.

Related Clinical Trials

NCT05591014 The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation COMPLETED NCT05588011 Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass COMPLETED NCT07146165 Clinical Evaluation of a New Platform for Bi-manual Endoscopic Resection in the Rectum and Sigma (EndoTEM) RECRUITING

Related Devices (Code: JPA)

K162688Sysmex CS-2100iSiemens Healthcare Diagnostics Products GmbH K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161317Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH K161312Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K151259Sysmex Automated Blood Coagulation Analyzer CS-2100iSiemens Healthcare Diagnostics Products GmbH K150678Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostic Products GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑