510(k) K033199 ยท KPS System, Tomography, Computed, Emission
COMPACT DIGITAL CARDIAC CAMERA (CDCC)
| Applicant | Is2 Medical Systems, Inc., Ottawa, Ontario, CA |
| Decision | Substantially Equivalent, Nov 12, 2003 |
| Received | Oct 2, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033199
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.