510(k) K003882 ยท KPS System, Tomography, Computed, Emission
NUCAMMA BI90
| Applicant | Is2 Research, Inc., Nepean, Ontario, CA |
| Decision | Substantially Equivalent, Feb 21, 2001 |
| Received | Dec 15, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003882
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.