510(k) K941995 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
NCE REPLACEMENT BATTERIES
| Applicant | National Custom Ent., Inc., Burnsville MN, US |
| Decision | Substantially Equivalent - Subject to Tracking Reg., Jul 26, 1994 |
| Received | Apr 25, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941995
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.