510(k) K970128 ยท KPS System, Tomography, Computed, Emission
ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
| Applicant | Park Medical Systems, Inc., Lachine Quebec, CA |
| Decision | Substantially Equivalent, Apr 11, 1997 |
| Received | Jan 14, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970128
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.