K201440 is an FDA 510(k) clearance for the ROTEM sigma Thromboelastometry System. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II - Special Controls, product code JPA).
Submitted by Tem Innovations GmbH (Munich, DE). The FDA issued a Cleared decision on July 8, 2022, 767 days after receiving the submission on June 1, 2020.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K201440 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2020 |
| Decision Date | July 08, 2022 |
| Days to Decision | 767 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JPA - System, Multipurpose For In Vitro Coagulation Studies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |