# K964869: Neurosign 800, 8 Channel Motor Nerve Monitor

- Pathway: 510(k) (Traditional)
- Applicant: The Magstim Company, Ltd.
- Decided: May 14, 1997 after 161 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
45 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K991583: Neurosign 400, 4 Channel Motor Nerve Monitor (1999), 44 descendants of its own
- K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe (2005), 38 descendants of its own
- K062996: Disposable Monopolar and Bipolar Stimulator Probes (2007), 32 descendants of its own
- K090838: Stimulus/Dissection Instruments (2009), 19 descendants of its own
- K063729: Disposable Pedicle Screw Probe, Model 3603-00 (2007), 19 descendants of its own

## Indications for use
The Neurosign 800 is intended to monitor and to stimulate cranial motor nerves. The motor nerves are monitored by detecting EMG activity in the muscles they innervate.

Source page: https://510kreport.com/device/K964869
Methodology: https://510kreport.com/methodology