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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233293
510(k) Type
Traditional
Applicant
NeuroSigma, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/16/2024
Days to Decision
109 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233293
510(k) Type
Traditional
Applicant
NeuroSigma, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/16/2024
Days to Decision
109 days
Submission Type
Summary