510(k) K970497 ยท DTE Pulse-Generator, Pacemaker, External
PACE 101H
| Applicant | Sulzer Oscor, Inc., Palm Harbor FL, US |
| Decision | Substantially Equivalent, Jun 4, 1997 |
| Received | Feb 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970497
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.