510(k) K033001 ยท KPS System, Tomography, Computed, Emission
APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4
| Applicant | Transphoton Corporation, Lunenburg MA, US |
| Decision | Substantially Equivalent, Dec 24, 2003 |
| Received | Sep 25, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033001
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.