510(k) K933073 ยท IZI System, X-Ray, Angiographic
HEARTTRACE LEFT VENTRICULAR ANALYSIS SOFTWARE
| Applicant | Heartware Intl. Corp., North Attleboro MA, US |
| Decision | Substantially Equivalent, Oct 7, 1993 |
| Received | Jun 23, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933073
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.