Last synced on 18 April 2025 at 11:05 pm

P-SCOPE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241502
510(k) Type
Traditional
Applicant
OUI Medical Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/24/2024
Days to Decision
57 days
Submission Type
Summary

P-SCOPE

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241502
510(k) Type
Traditional
Applicant
OUI Medical Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/24/2024
Days to Decision
57 days
Submission Type
Summary