510(k) K103242 ยท ODX Autonomous Extracorporeal Blood Leak Detector/Alarm
REDSENSE-ALARM UNIT AND SENSOR
| Applicant | Redsense Medical AB, Fridley MN, US |
| Decision | Substantially Equivalent, Feb 10, 2011 |
| Received | Nov 2, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103242
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.