FDA 510(k)

Ergoline Prestige 1600 Hybrid Performance

N.º K: K180555 · 2018-10-11

Fecha de decisión2018-10-11

Código de productoLEJ

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ergoline Prestige 1600 Hybrid Performance is the device name listed in this FDA 510(k) record. The listed applicant is Jk Holding GmbH. It received FDA 510(k) clearance on 2018-10-11 under 510(k) number K180555. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Ergoline Prestige 1600 Hybrid Performance?

Ergoline Prestige 1600 Hybrid Performance is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is Jk Holding GmbH. The 510(k) number is K180555.

When did Ergoline Prestige 1600 Hybrid Performance receive FDA 510(k) clearance?

Ergoline Prestige 1600 Hybrid Performance received FDA 510(k) clearance on 2018-10-11, under 510(k) number K180555.

Who is the listed applicant for Ergoline Prestige 1600 Hybrid Performance?

The FDA 510(k) record lists Jk Holding GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ergoline Prestige 1600 Hybrid Performance?

The FDA product code for Ergoline Prestige 1600 Hybrid Performance is LEJ.

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Otros registros que enlistan a Jk Holding GmbH como solicitante

K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline K190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound K183539Ergoline Sunrise 7200 Hybrid Technology K173565Sunrise 6200, Sunrise 7200

Dispositivos relacionados (Código: LEJ)

K221523Tanning LampUnilam Co., Ltd.K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by ErgolineJk-Holding GmbH K191881KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunKbl GmbH K190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundJk-Holding GmbH K183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbH K181455ProSun sunlamp products, Luxura sunlamp productsProsun International, LLC

Fuente oficial

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