FDA 510(k)

JKH Stimulator Plus

N.º K: K182203 · 2019-03-14

Fecha de decisión2019-03-14

Código de productoNUH

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

JKH Stimulator Plus is the device name listed in this FDA 510(k) record. The listed applicant is Jkh USA, LLC. It received FDA 510(k) clearance on 2019-03-14 under 510(k) number K182203. The device is classified under product code NUH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the JKH Stimulator Plus?

JKH Stimulator Plus is a medical device that received FDA 510(k) clearance on 2019-03-14. The listed applicant is Jkh USA, LLC. The 510(k) number is K182203.

When did JKH Stimulator Plus receive FDA 510(k) clearance?

JKH Stimulator Plus received FDA 510(k) clearance on 2019-03-14, under 510(k) number K182203.

Who is the listed applicant for JKH Stimulator Plus?

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

What is the FDA product code for JKH Stimulator Plus?

The FDA product code for JKH Stimulator Plus is NUH.

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Otros registros que enlistan a Jkh USA, LLC como solicitante

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Fuente oficial

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