510(k) K113214 ยท DXJ Display, Cathode-Ray Tube, Medical
TLINK DATA MANAGEMENT SYSTEM (DMS)
| Applicant | Terumo Cardiovascular Systems Corp., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Feb 7, 2012 |
| Received | Oct 31, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113214
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.