X-trodes System M— 510(k) K232210

Substantially Equivalent

X-Trodes

FDA 510(k) clearance K232210 for X-trodes System M, Substantially Equivalent on 2024-02-04. Applicant: X-Trodes. Device class: 2.

Clearance details

Applicant: X-Trodes
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2023-07-26
Decision date: 2024-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Herzeliya, IL

Download summary PDF View on FDA.gov ↗

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