510(k) K912775 ยท GWF Stimulator, Electrical, Evoked Response
SAPPHIRE 4ME EMG/EP SYSTEM
| Applicant | Medelec Intl. Corp., England, GB |
| Decision | Substantially Equivalent, Nov 8, 1991 |
| Received | Jun 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912775
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.