Ergoline Sunrise 7200 Hybrid Technology
K号: K183539 · 2019-04-08
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器械摘要
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.
常见问题
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.
相关临床试验
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列明Jk-Holding GmbH为申报人的其他记录
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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
相关器械（代码：LEJ）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K221523晒黑灯Unilam 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 太阳灯产品，Luxura 太阳灯产品Prosun International, LLC
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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