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REMI Remote EEG Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230933
510(k) Type
Traditional
Applicant
Epitel, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/2023
Days to Decision
88 days
Submission Type
Summary

REMI Remote EEG Monitoring System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230933
510(k) Type
Traditional
Applicant
Epitel, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/30/2023
Days to Decision
88 days
Submission Type
Summary