510(k) K011980 ยท DTE Pulse-Generator, Pacemaker, External
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
| Applicant | Pace Medical, Waltham MA, US |
| Decision | Substantially Equivalent, Sep 12, 2001 |
| Received | Jun 25, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011980
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.