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FDA 510(k)

uwe sun 晒肤床/亭 P90，iBED EVG，iSUN HP，SILVERBULLET SE，LOTUS

K号: K152364 · 2016-04-14

申请人Pc Marketing, Inc.
决定日期2016-04-14
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

uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS is the device name listed in this FDA 510(k) record. The listed applicant is Pc Marketing, Inc.. It received FDA 510(k) clearance on 2016-04-14 under 510(k) number K152364. 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 uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS?

uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS is a medical device that received FDA 510(k) clearance on 2016-04-14. The listed applicant is Pc Marketing, Inc.. The 510(k) number is K152364.

When did uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS receive FDA 510(k) clearance?

uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS received FDA 510(k) clearance on 2016-04-14, under 510(k) number K152364.

Who is the listed applicant for uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS?

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

What is the FDA product code for uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS?

The FDA product code for uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS 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。

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官方来源

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