FDA 510(k)

UV Radiation Treatment System

N.º K: K191571 · 2020-02-06

SolicitanteXuzhou Yongkang Electronic Science Technology Co., Ltd.

Fecha de decisión2020-02-06

Código de productoFTC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

UV Radiation Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Yongkang Electronic Science Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K191571. 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 UV Radiation Treatment System?

UV Radiation Treatment System is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Xuzhou Yongkang Electronic Science Technology Co., Ltd.. The 510(k) number is K191571.

When did UV Radiation Treatment System receive FDA 510(k) clearance?

UV Radiation Treatment System received FDA 510(k) clearance on 2020-02-06, under 510(k) number K191571.

Who is the listed applicant for UV Radiation Treatment System?

The FDA 510(k) record lists Xuzhou Yongkang Electronic Science Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UV Radiation Treatment System?

The FDA product code for UV Radiation Treatment System is FTC.

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Otros registros que enlistan a Xuzhou Yongkang Electronic Science Technology Co., Ltd. como solicitante

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Dispositivos relacionados (Código: FTC)

K254234Phototherapy System (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLC K250425Ultraviolet Phototherapy DeviceAPK Technology Co., Ltd.K244022Sistema de Fototerapia UV de 308nm (UV-K); Sistema de Fototerapia UV de 308nm (UV-X); Sistema de Fototerapia UV de 308nm (UV-Y); Sistema de Fototerapia UV de 308nm (UV-Z)Boston Aesthetics, Inc.K242977Dispositivo de fototerapia de excímero de 308 nm (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)Xuzhou Kernel Medical Equipment Co., Ltd.K242908UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)Shanghai Sigma High-Tech Co., Ltd.

Fuente oficial

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