The following data is part of a premarket notification filed by Tem Innovations Gmbh with the FDA for Rotem Sigma Thromboelastometry System.
| Device ID | K201440 |
| 510k Number | K201440 |
| Device Name: | ROTEM Sigma Thromboelastometry System |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | Tem Innovations GmbH Martin-Kollar-Strasse 15 Munich, DE 81829 |
| Contact | David Jacob |
| Correspondent | David Jacob Tem Innovations GmbH Martin-Kollar-Strasse 15 Munich, DE 81829 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-01 |
| Decision Date | 2022-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260160470372 | K201440 | 000 |
| 04260160470600 | K201440 | 000 |