510(k) K963273 ยท KPS System, Tomography, Computed, Emission
VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION
| Applicant | Smv America, Twinsburg OH, US |
| Decision | Substantially Equivalent, Mar 11, 1997 |
| Received | Aug 20, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963273
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.