510(k) K970347 ยท DTE Pulse-Generator, Pacemaker, External
MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
| Applicant | Paladin Medical, Inc., Stillwater MN, US |
| Decision | Substantially Equivalent, Aug 29, 1997 |
| Received | Jan 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970347
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.