SMK, CX, CXE, RCN— 510(k) K042375

Clearance details

Applicant

Technomed Europe

Product code

Code GXI

Device class

Class 2

Regulation

21 CFR 882.4725

Advisory panel

Neurology

Date received

2004-09-01

Decision date

2004-10-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Maastricht-Airport, NL

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Death

3

Injury

171

Total

174

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 →