510(k) K971194 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES
| Applicant | Nihon Kohden America, Inc., Irvine CA, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jul 9, 1997 |
| Received | Apr 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971194
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.