FDA 510(k)

LUMINELLE DTx System

N.º K: K210512 · 2021-06-30

Fecha de decisión2021-06-30

Código de productoFAJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Uvision360, Inc. como solicitante

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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Fuente oficial

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