510(k) K972229 ยท IZI System, X-Ray, Angiographic
IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM
| Applicant | Heartware, Inc., North Attleboro MA, US |
| Decision | Substantially Equivalent, Oct 16, 1997 |
| Received | Jun 13, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972229
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.