Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®— 510(k) K233293

Name: FDA 510(k) clearance K233293
Creator: U.S. Food and Drug Administration
Published: 2024-01-16

Substantially Equivalent

Neurosigma, Inc.

FDA 510(k) clearance K233293 for Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®, Substantially Equivalent on 2024-01-16. Applicant: Neurosigma, Inc.. Device class: 2.

Clearance details

Applicant: Neurosigma, Inc.
Product code: Code QGL
Device class: Class 2
Regulation: 21 CFR 882.5898
Advisory panel: Neurology
Date received: 2023-09-29
Decision date: 2024-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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