Last synced on 2 May 2025 at 11:05 pm

Apex Locator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242383
510(k) Type
Traditional
Applicant
Shenzhen Rogin Medical Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
3/7/2025
Days to Decision
207 days
Submission Type
Summary

Apex Locator

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K242383
510(k) Type
Traditional
Applicant
Shenzhen Rogin Medical Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
3/7/2025
Days to Decision
207 days
Submission Type
Summary