FDA 510(k)

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

Número K: K161055 · 2016-07-12

Data da decisão2016-07-12

Código do produtoKPI

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 is the device name listed in this FDA 510(k) record. The listed applicant is Fuji Dynamics , Ltd.. It received FDA 510(k) clearance on 2016-07-12 under 510(k) number K161055. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15?

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 is a medical device that received FDA 510(k) clearance on 2016-07-12. The listed applicant is Fuji Dynamics , Ltd.. The 510(k) number is K161055.

When did Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 receive FDA 510(k) clearance?

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 received FDA 510(k) clearance on 2016-07-12, under 510(k) number K161055.

Who is the listed applicant for Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15?

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

What is the FDA product code for Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15?

The FDA product code for Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15 is KPI.

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