510(k) K912507 ยท DTE Pulse-Generator, Pacemaker, External
CPI MODEL 2215 & SEAMED MODEL 3400
| Applicant | Seamed Corp., Bothell WA, US |
| Decision | Substantially Equivalent, Sep 3, 1991 |
| Received | Jun 6, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912507
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.