FDA 510(k)

LUMINELLE DTx System

Número K: K210512 · 2021-06-30

Data da decisão2021-06-30

Código do produtoFAJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LUMINELLE DTx System is the device name listed in this FDA 510(k) record. The listed applicant is Uvision360, Inc.. It received FDA 510(k) clearance on 2021-06-30 under 510(k) number K210512. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the LUMINELLE DTx System?

LUMINELLE DTx System is a medical device that received FDA 510(k) clearance on 2021-06-30. The listed applicant is Uvision360, Inc.. The 510(k) number is K210512.

When did LUMINELLE DTx System receive FDA 510(k) clearance?

LUMINELLE DTx System received FDA 510(k) clearance on 2021-06-30, under 510(k) number K210512.

Who is the listed applicant for LUMINELLE DTx System?

The FDA 510(k) record lists Uvision360, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LUMINELLE DTx System?

The FDA product code for LUMINELLE DTx System is FAJ.

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Outros registros que listam Uvision360, Inc. como candidato(a)

K192278Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid K181909Luminelle DTx Hysteroscopy System

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