510(k) K864988 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
ETP 180E NON-INVASIVE EXTERNAL PACEMAKER
| Applicant | Medac, Inc., Tualatin OR, US |
| Decision | Substantially Equivalent, Mar 3, 1987 |
| Received | Dec 22, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864988
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.