510(k) K042628 ยท DQK Computer, Diagnostic, Programmable
MODIFICATION TO: RADIANALYZER, MODEL 12711
| Applicant | Radi Medical Systems AB, Uppsala, SE |
| Decision | Substantially Equivalent, Jan 19, 2005 |
| Received | Sep 27, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042628
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.