DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,— 510(k) K130136

Clearance details

Applicant

Technomed Europe

Product code

Code GXZ

Device class

Class 2

Regulation

21 CFR 882.1350

Advisory panel

Neurology

Date received

2013-01-18

Decision date

2013-07-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Maastricht-Airport, NL

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130136.