FDA 510(k)

Sistema Excimer de 308nm

N.º K: K192642 · 2020-05-13

SolicitanteChongqing Peninsula Medical Technology Co., Ltd.

Fecha de decisión2020-05-13

Código de productoFTC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

308nm Excimer System is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Peninsula Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-13 under 510(k) number K192642. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 308nm Excimer System?

308nm Excimer System is a medical device that received FDA 510(k) clearance on 2020-05-13. The listed applicant is Chongqing Peninsula Medical Technology Co., Ltd.. The 510(k) number is K192642.

When did 308nm Excimer System receive FDA 510(k) clearance?

308nm Excimer System received FDA 510(k) clearance on 2020-05-13, under 510(k) number K192642.

Who is the listed applicant for 308nm Excimer System?

The FDA 510(k) record lists Chongqing Peninsula Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 308nm Excimer System?

The FDA product code for 308nm Excimer System is FTC.

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Otros registros que enlistan a Chongqing Peninsula Medical Technology Co., Ltd. como solicitante

K192552Irradiation Cosmetic Device K172273Sistema Excimer de 308nm K171835Irradiation Aesthetic Device

Dispositivos relacionados (Código: FTC)

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Fuente oficial

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