510(k) K964438 ยท KPS System, Tomography, Computed, Emission
511 KEV COLLIMATOR
| Applicant | Trionix Research Laboratory, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, May 29, 1997 |
| Received | Nov 5, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964438
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.