510(k) K201440
K201440 is an FDA 510(k) premarket notification submitted by Tem Innovations GmbH for the device "ROTEM sigma Thromboelastometry System". The FDA issued a decision of Substantially Equivalent on July 8, 2022. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Tem Innovations GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 8, 2022
- Date Received
- June 1, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Multipurpose For In Vitro Coagulation Studies
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type