Data da decisão2019-04-08
Código do produtoLEJ
Comité consultivoSU
DecisãoSubstantially Equivalent
Resumo do dispositivo
Ergoline Sunrise 7200 Hybrid Technology 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 2019-04-08 under 510(k) number K183539. 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 Sunrise 7200 Hybrid Technology?
Ergoline Sunrise 7200 Hybrid Technology is a medical device that received FDA 510(k) clearance on 2019-04-08. The listed applicant is Jk-Holding GmbH. The 510(k) number is K183539.
When did Ergoline Sunrise 7200 Hybrid Technology receive FDA 510(k) clearance?
Ergoline Sunrise 7200 Hybrid Technology received FDA 510(k) clearance on 2019-04-08, under 510(k) number K183539.
Who is the listed applicant for Ergoline Sunrise 7200 Hybrid Technology?
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 Sunrise 7200 Hybrid Technology?
The FDA product code for Ergoline Sunrise 7200 Hybrid Technology is LEJ.
Ensaios clínicos relacionados
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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 / SoundK180555Ergoline Prestige 1600 Hybrid PerformanceK173565Sunrise 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 GmbHK180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbHK181455ProSun sunlamp products, Luxura sunlamp productsProsun International, LLC
Fonte oficial
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