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FDA 510(k)

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®

K-Number: K233293 · 2024-01-16

ApplicantNeurosigma, Inc.
Decision Date2024-01-16
Product CodeQGL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is the device name listed in this FDA 510(k) record. The listed applicant is Neurosigma, Inc.. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K233293. The device is classified under product code QGL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®?

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Neurosigma, Inc.. The 510(k) number is K233293.

When did Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® receive FDA 510(k) clearance?

Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® received FDA 510(k) clearance on 2024-01-16, under 510(k) number K233293.

Who is the listed applicant for Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®?

The FDA 510(k) record lists Neurosigma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System®?

The FDA product code for Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® is QGL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07656129Immediate Effects of External Trigeminal Nerve Stimulation on Motor Dysfunction in Parkinson's DiseaseNOT_YET_RECRUITINGNCT07668167Combined Regulatory Effects of 40 Hz eTNS and Multisensory Stimulation on Brain NetworksRECRUITINGNCT05374187Efficacy of Trigeminal Nerve Stimulation for ADHDCOMPLETEDNCT06788977External Trigeminal Nerve Stimulation for Migraine Treatment in PregnancyRECRUITINGNCT07657260Investigating the Transcutaneous vs. Transcranial Mechanisms of Trigeminal Nerve Stimulation (eTNS) Using fMRIRECRUITINGNCT07662291Frequency Effects of Transcutaneous Trigeminal Nerve Stimulation (eTNS) on Brain and Autonomic FunctionRECRUITING

Related Devices (Code: QGL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243289ADDNOX (BPSPM1)Nu Eyne Co., Ltd.K232991BT-1000Bistos Co., Ltd.K213629SMILENu Eyne Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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