510(k) K923056 ยท ETN Stimulator, Nerve
NEUROSIGN MODEL 100
| Applicant | The Magstim Company , Ltd., Carmarthenshire, GB |
| Decision | Substantially Equivalent, Nov 24, 1992 |
| Received | Jun 24, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K923056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2020 | The Magstim Company Limited Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT Terminated |
ETN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.