510(k) K854196 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
DCI MODEL EP-2 CLINICAL STIMULATOR
| Applicant | Digital Cardiovascular Instruments, Inc., Emeryville CA, US |
| Decision | Substantially Equivalent, May 1, 1986 |
| Received | Oct 15, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854196
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.