Last synced on 23 February 2024 at 11:04 pm

Cystoscope System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231118
510(k) Type
Traditional
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/13/2023
Days to Decision
207 days
Submission Type
Summary

Cystoscope System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K231118
510(k) Type
Traditional
Applicant
Shenzhen HugeMed Medical Technical Development Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/13/2023
Days to Decision
207 days
Submission Type
Summary