510(k) K961138 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
ESORT II + 400 SERIES MONITOR
| Applicant | Medical Data Electronics, Arleta CA, US |
| Decision | Substantially Equivalent, Dec 10, 1996 |
| Received | Mar 21, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961138
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.