Last synced on 14 November 2025 at 11:06 pm

POTENZA

Page Type
Cleared 510(K)
510(k) Number
K231216
510(k) Type
Traditional
Applicant
Jeisys Medical Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/10/2024
Days to Decision
592 days
Submission Type
Summary

POTENZA

Page Type
Cleared 510(K)
510(k) Number
K231216
510(k) Type
Traditional
Applicant
Jeisys Medical Inc.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
12/10/2024
Days to Decision
592 days
Submission Type
Summary