510(k) K933058 ยท IZI System, X-Ray, Angiographic
HEARTTRACK QUANTITATIVE CORONARY ANGIOGRAPHY SOFTW
| Applicant | Heartware Intl. Corp., North Attleboro MA, US |
| Decision | Substantially Equivalent, Sep 28, 1993 |
| Received | Jun 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933058
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.