510(k) K010391 ยท IZI System, X-Ray, Angiographic
ATLAS MULTI-PURPOSE DSA SYSTEM
| Applicant | Cares Built, Inc., Keyport NJ, US |
| Decision | Substantially Equivalent, Mar 12, 2001 |
| Received | Feb 9, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010391
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.