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FDA 510(k)

Diode Laser Treatment System

N.º K: K182924 · 2019-04-15

SolicitanteWeifang KM Electronics Co., Ltd.
Fecha de decisión2019-04-15
Código de productoGEX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Diode Laser Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Weifang KM Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K182924. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Diode Laser Treatment System?

Diode Laser Treatment System is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Weifang KM Electronics Co., Ltd.. The 510(k) number is K182924.

When did Diode Laser Treatment System receive FDA 510(k) clearance?

Diode Laser Treatment System received FDA 510(k) clearance on 2019-04-15, under 510(k) number K182924.

Who is the listed applicant for Diode Laser Treatment System?

The FDA 510(k) record lists Weifang KM Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser Treatment System?

The FDA product code for Diode Laser Treatment System is GEX. This falls under the Gastroenterology category.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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