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HJY VisualNext Endoscopic Vision System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222735
510(k) Type
Traditional
Applicant
HJY Smart Medical Device Co., Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
7/28/2023
Days to Decision
322 days
Submission Type
Summary

HJY VisualNext Endoscopic Vision System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K222735
510(k) Type
Traditional
Applicant
HJY Smart Medical Device Co., Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
7/28/2023
Days to Decision
322 days
Submission Type
Summary