510(k) K982045 ยท KPS System, Tomography, Computed, Emission
NUCAMMA RX
| Applicant | Is2 Research, Inc., Nepean, Ontario, CA |
| Decision | Substantially Equivalent, Sep 2, 1998 |
| Received | Jun 10, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982045
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.