Clearance Summary
ROTEM sigma Thromboelastometry System received FDA 510(k) clearance under submission number K201440, sponsored by Tem Innovations GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2022-07-08.
- Submission: K201440
- Applicant / Sponsor: Tem Innovations GmbH
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5425
- Decision date: 2022-07-08
Classification & Regulation
This clearance is catalogued under FDA product code JPA and 21 CFR 864.5425, within the Hematology review panel as a Class II device.