Disposable Subdermal Needle Electrode, Corkscrew— 510(k) K241045

Name: FDA 510(k) clearance K241045
Creator: U.S. Food and Drug Administration
Published: 2024-12-11

Substantially Equivalent

Technomed Europe

FDA 510(k) clearance K241045 for Disposable Subdermal Needle Electrode, Corkscrew, Substantially Equivalent on 2024-12-11. Applicant: Technomed Europe. Device class: 2.

Clearance details

Applicant: Technomed Europe
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2024-04-17
Decision date: 2024-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maastricht-Airport, NL

Download summary PDF View on FDA.gov ↗

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