Last synced on 6 December 2024 at 11:05 pm

Digital ClarusScope System, Digital NeuroPEN System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223615
510(k) Type
Traditional
Applicant
Clarus Medical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/21/2023
Days to Decision
351 days
Submission Type
Summary

Digital ClarusScope System, Digital NeuroPEN System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K223615
510(k) Type
Traditional
Applicant
Clarus Medical, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/21/2023
Days to Decision
351 days
Submission Type
Summary