510(k) K864985 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE
| Applicant | Medac, Inc., Tualatin OR, US |
| Decision | Substantially Equivalent, Mar 10, 1987 |
| Received | Dec 22, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864985
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.