FDA 510(k)

Advance Medical Designs, Inc. Gel Ultrasónico Estéril

N.º K: K163050 · 2017-10-25

SolicitanteAdvance Medical Designs, Inc.

Fecha de decisión2017-10-25

Código de productoMUI

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

Advance Medical Designs, Inc. Sterile Ultrasound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Advance Medical Designs, Inc.. It received FDA 510(k) clearance on 2017-10-25 under 510(k) number K163050. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Advance Medical Designs, Inc. Sterile Ultrasound Gel?

Advance Medical Designs, Inc. Sterile Ultrasound Gel is a medical device that received FDA 510(k) clearance on 2017-10-25. The listed applicant is Advance Medical Designs, Inc.. The 510(k) number is K163050.

When did Advance Medical Designs, Inc. Sterile Ultrasound Gel receive FDA 510(k) clearance?

Advance Medical Designs, Inc. Sterile Ultrasound Gel received FDA 510(k) clearance on 2017-10-25, under 510(k) number K163050.

Who is the listed applicant for Advance Medical Designs, Inc. Sterile Ultrasound Gel?

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

What is the FDA product code for Advance Medical Designs, Inc. Sterile Ultrasound Gel?

The FDA product code for Advance Medical Designs, Inc. Sterile Ultrasound Gel is MUI.

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Dispositivos relacionados (Código: MUI)

K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelFoshan Pingchuang Medical Technology Co., Ltd.K252337EdgeFlow Gel PadEdgecare, Inc.K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.K221999Ultrasound Transmission GelsHony Medical Co., Ltd.

Fuente oficial

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