510(k) K894492 ยท DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
NKA MODEL SEC-3102 CARDIAC STIMULATOR
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 20, 1989 |
| Received | Jul 18, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894492
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.