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Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192278
510(k) Type
Special
Applicant
UVision360 Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/1/2019
Days to Decision
71 days
Submission Type
Summary

Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K192278
510(k) Type
Special
Applicant
UVision360 Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/1/2019
Days to Decision
71 days
Submission Type
Summary