510(k) K013620 ยท IZF System, X-Ray, Tomographic
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
| Applicant | Medstone Intl., Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Jan 22, 2002 |
| Received | Nov 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013620
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.