免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

3400E 系列产品；E5400 系列产品；E6400 系列产品；Sundazzler 系列产品

K号: K151905 · 2016-03-01

申请人Heartland Tanning, Inc.
决定日期2016-03-01
产品代码LEJ
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

3400E series; E5400 series; E6400 series; Sundazzler series is the device name listed in this FDA 510(k) record. The listed applicant is Heartland Tanning, Inc.. It received FDA 510(k) clearance on 2016-03-01 under 510(k) number K151905. 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 3400E series; E5400 series; E6400 series; Sundazzler series?

3400E series; E5400 series; E6400 series; Sundazzler series is a medical device that received FDA 510(k) clearance on 2016-03-01. The listed applicant is Heartland Tanning, Inc.. The 510(k) number is K151905.

When did 3400E series; E5400 series; E6400 series; Sundazzler series receive FDA 510(k) clearance?

3400E series; E5400 series; E6400 series; Sundazzler series received FDA 510(k) clearance on 2016-03-01, under 510(k) number K151905.

Who is the listed applicant for 3400E series; E5400 series; E6400 series; Sundazzler series?

The FDA 510(k) record lists Heartland Tanning, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3400E series; E5400 series; E6400 series; Sundazzler series?

The FDA product code for 3400E series; E5400 series; E6400 series; Sundazzler series is LEJ.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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 GmbHK183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbHK180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbH

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。

↑