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REMI-AI Rapid Detection Module (REMI-AI RDM)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240408
510(k) Type
Traditional
Applicant
Epitel, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/17/2024
Days to Decision
251 days
Submission Type
Summary

REMI-AI Rapid Detection Module (REMI-AI RDM)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240408
510(k) Type
Traditional
Applicant
Epitel, Inc
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/17/2024
Days to Decision
251 days
Submission Type
Summary