510(k) K052908 ยท DQO Catheter, Intravascular, Diagnostic
INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5
| Applicant | Infraredx, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Jun 23, 2006 |
| Received | Oct 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052908
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.