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NEUROMARK System (NMK00301)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K250048
510(k) Type
Traditional
Applicant
Neurent Medical Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
5/29/2025
Days to Decision
139 days
Submission Type
Summary

NEUROMARK System (NMK00301)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K250048
510(k) Type
Traditional
Applicant
Neurent Medical Ltd.
Country
Ireland
FDA Decision
Substantially Equivalent
Decision Date
5/29/2025
Days to Decision
139 days
Submission Type
Summary