510(k) K011611 ยท KPS System, Tomography, Computed, Emission
CARDIOCAM MODEL 9CSY0799
| Applicant | Danish Diagnostic Development A/S, Horsholm, DK |
| Decision | Substantially Equivalent, Jun 8, 2001 |
| Received | May 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011611
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Adac Labs Emission Computed Tomography System Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.