510(k) K954391 ยท DRL Tester, Defibrillator
MODELS QED-6, 6M AND 6H DEFIBRILLATOR ANALYZER WITH OPTIONAL UNIVERSAL PACEMAKER LOAD ADAPTER
| Applicant | Bio-Tek Instruments, Inc., Winooski VT, US |
| Decision | Substantially Equivalent, Nov 17, 1995 |
| Received | Sep 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954391
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.