Neuromaster G1 MEE200— 510(k) K142624

Substantially Equivalent

Nihon Kohden Corporation

FDA 510(k) clearance K142624 for Neuromaster G1 MEE200, Substantially Equivalent on 2015-04-24. Applicant: Nihon Kohden Corporation.

Clearance details

Applicant: Nihon Kohden Corporation
Product code: Code GWF
Advisory panel: Neurology
Date received: 2014-09-16
Decision date: 2015-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code GWF

product code GWF

Malfunction: 2,364
Other: 4
Total: 2,368

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.