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Monarch eTNS System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN180041
510(k) Type
Direct
Applicant
NeuroSigma, Inc
Country
United States
FDA Decision
Deleted
Decision Date
4/19/2019
Days to Decision
263 days

Monarch eTNS System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN180041
510(k) Type
Direct
Applicant
NeuroSigma, Inc
Country
United States
FDA Decision
Deleted
Decision Date
4/19/2019
Days to Decision
263 days