510(k) K092955 ยท ODX Autonomous Extracorporeal Blood Leak Detector/Alarm
REDSENSE-HOME USE
| Applicant | Redsense Medical AB, Fridley MN, US |
| Decision | Substantially Equivalent, May 10, 2010 |
| Received | Sep 25, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092955
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.