Last synced on 25 January 2026 at 3:41 am

Density

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230663
510(k) Type
Traditional
Applicant
Jeisys Medical, Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/14/2023
Days to Decision
157 days
Submission Type
Summary

Density

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230663
510(k) Type
Traditional
Applicant
Jeisys Medical, Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
8/14/2023
Days to Decision
157 days
Submission Type
Summary