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FDA 510(k)

R2 皮肤冷却系统

K号: K161480 · 2016-10-05

申请人R2 Dermatology
决定日期2016-10-05
产品代码GEH
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

R2 Dermal Cooling System is the device name listed in this FDA 510(k) record. The listed applicant is R2 Dermatology. It received FDA 510(k) clearance on 2016-10-05 under 510(k) number K161480. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the R2 Dermal Cooling System?

R2 Dermal Cooling System is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is R2 Dermatology. The 510(k) number is K161480.

When did R2 Dermal Cooling System receive FDA 510(k) clearance?

R2 Dermal Cooling System received FDA 510(k) clearance on 2016-10-05, under 510(k) number K161480.

Who is the listed applicant for R2 Dermal Cooling System?

The FDA 510(k) record lists R2 Dermatology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for R2 Dermal Cooling System?

The FDA product code for R2 Dermal Cooling System is GEH.

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：GEH）

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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