FDA 510(k)

Ergoline Sunrise 7200 Hybrid Technology

Numéro K : K183539 · 2019-04-08

Date de décision2019-04-08

Code produitLEJ

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Jk-Holding GmbH en tant que demandeur

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 K180555Ergoline Prestige 1600 Hybrid Performance K173565Sunrise 6200, Sunrise 7200

Dispositifs connexes (Code : 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 K180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH K181455ProSun sunlamp products, Luxura sunlamp productsProsun International, LLC

Source officielle

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