510(k) K993765 ยท IZI System, X-Ray, Angiographic
QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
| Applicant | Medis Medical Imaging Systems BV, Ridgefield CT, US |
| Decision | Substantially Equivalent, Nov 26, 1999 |
| Received | Nov 8, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K993765
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.