510(k) K201440 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
ROTEM sigma Thromboelastometry System
| Applicant | Tem Innovations GmbH, Munich, DE |
| Decision | Substantially Equivalent, Jul 8, 2022 |
| Received | Jun 1, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201440
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.