FDA 510(k)

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

Número K: K223926 · 2023-10-06

RequerenteMedimaging Integrated Solution, Inc (Miis)

Data da decisão2023-10-06

Código do produtoFAJ

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is the device name listed in this FDA 510(k) record. The listed applicant is Medimaging Integrated Solution, Inc (Miis). It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K223926. 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 VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is Medimaging Integrated Solution, Inc (Miis). The 510(k) number is K223926.

When did VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box receive FDA 510(k) clearance?

VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box received FDA 510(k) clearance on 2023-10-06, under 510(k) number K223926.

Who is the listed applicant for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

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

What is the FDA product code for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box?

The FDA product code for VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box is FAJ.

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Fonte oficial

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