510(k) K130554 ยท ODX Autonomous Extracorporeal Blood Leak Detector/Alarm
REDSENSE ALARM SYSTEM
| Applicant | Redsense Medical AB, Halmstad, SE |
| Decision | Substantially Equivalent, Nov 22, 2013 |
| Received | Mar 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130554
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.