510(k) K955026 ยท KOI Stimulator, Nerve, Peripheral, Electric
AS/3 NMT MODULE
| Applicant | Datex Medical Instrumentation, Inc., Tewksbury MA, US |
| Decision | Substantially Equivalent, Apr 28, 1997 |
| Received | Nov 2, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955026
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 21, 2014 | GE Healthcare, LLC GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01
Product Usage:
The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation Terminated |
KOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.