510(k) K040057 ยท KPS System, Tomography, Computed, Emission
MOBILE COMPACT DIGITAL CARDIAC CAMERA
| Applicant | Is2 Research, Inc., Ottawa, Ontario, CA |
| Decision | Substantially Equivalent, Feb 2, 2004 |
| Received | Jan 13, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040057
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.