510(k) K111985 ยท BXN Stimulator, Nerve, Battery-Powered
MYOGUIDE SYSTEM MODEL 8008
| Applicant | Intronix Technologies Corp., Austin TX, US |
| Decision | Substantially Equivalent, Dec 30, 2011 |
| Received | Jul 12, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111985
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.