Data da decisão2018-10-11
Código do produtoLEJ
Comité consultivoSU
DecisãoSubstantially Equivalent
Resumo do 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.
Perguntas frequentes
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.
Ensaios clínicos relacionados
Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.
Outros registros que listam Jk Holding GmbH como candidato(a)
Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.
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 ErgolineK190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundK183539Ergoline Sunrise 7200 Hybrid TechnologyK173565Sunrise 6200, Sunrise 7200
Dispositivos Relacionados (Código: LEJ)
Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.
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 GmbHK191881KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSunKbl GmbHK190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundJk-Holding GmbHK183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbHK181455ProSun sunlamp products, Luxura sunlamp productsProsun International, LLC
Fonte oficial
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