510(k) K854853 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
NI-PACER 1
| Applicant | Associated Medical Devices, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Feb 14, 1986 |
| Received | Dec 5, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854853
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.