510(k) K914971 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 4, 1991 |
| Received | Oct 18, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K914971
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.