510(k) K071378 ยท JAK System, X-Ray, Tomography, Computed
MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
| Applicant | E-Z-Em, Inc., Westbury NY, US |
| Decision | Substantially Equivalent, Jun 13, 2007 |
| Received | May 17, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071378
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.