Source document or public record
FDA 510(k) K201440 — ROTEM sigma Thromboelastometry System
FDA 510(k) index record K201440. Device: ROTEM sigma Thromboelastometry System. Applicant as listed: Tem Innovations GmbH. Decision date: 2022-07-08.
Source
"device_name": "ROTEM sigma Thromboelastometry System"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K201440.
Device name: ROTEM sigma Thromboelastometry System. Applicant as listed: Tem Innovations GmbH.
Decision date: 2022-07-08. Decision wording: Substantially Equivalent.
Product code: JPA. Regulation: 21 CFR 864.5425. Medical specialty: Hematology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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