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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 the device name listed in this FDA 510(k) record. The listed applicant is Tem Innovations GmbH. It received FDA 510(k) clearance on 2022-07-08 under 510(k) 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. The listed applicant is Tem Innovations GmbH. The 510(k) number is K201440.

When did ROTEM sigma Thromboelastometry System receive FDA 510(k) clearance?

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

Who is the listed applicant for ROTEM sigma Thromboelastometry System?

The FDA 510(k) record lists Tem Innovations GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

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Official Source

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

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