510(k) K053141— NEUROSIGN MOTOR NERVE MONITOR, MODELS NEUROSIGN 400 & 800

Substantially Equivalent

The Magstim Company , Ltd.

Clearance details

Applicant: The Magstim Company , Ltd.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2005-11-09
Decision date: 2005-12-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Whitland, Dyfed Wales, GB

Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.