510(k) K854924 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
AMI E-Z-PACE ELECTODE
| Applicant | A.M.I. Corp., Lawrence MA, US |
| Decision | Substantially Equivalent, Feb 26, 1986 |
| Received | Dec 10, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854924
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.