510(k) K854117 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
AMENDMENT LIFEPAK 8, NPN 052
| Applicant | Physio-Control Corp., Redmond WA, US |
| Decision | Substantially Equivalent, Jan 13, 1986 |
| Received | Oct 9, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854117
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.