510(k) K882168 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
EXTERNAL PACEMAKER 2000 (EP2000)
| Applicant | Unomed, Inc., Ft. Myers FL, US |
| Decision | Substantially Equivalent, Aug 19, 1988 |
| Received | May 24, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K882168
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.