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FDA 510(k)

DigniCap Delta

K号: K191166 · 2019-06-26

申请人Dignitana, Inc.
决定日期2019-06-26
产品代码PMC
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

DigniCap Delta is the device name listed in this FDA 510(k) record. The listed applicant is Dignitana, Inc.. It received FDA 510(k) clearance on 2019-06-26 under 510(k) number K191166. The device is classified under product code PMC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the DigniCap Delta?

DigniCap Delta is a medical device that received FDA 510(k) clearance on 2019-06-26. The listed applicant is Dignitana, Inc.. The 510(k) number is K191166.

When did DigniCap Delta receive FDA 510(k) clearance?

DigniCap Delta received FDA 510(k) clearance on 2019-06-26, under 510(k) number K191166.

Who is the listed applicant for DigniCap Delta?

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

What is the FDA product code for DigniCap Delta?

The FDA product code for DigniCap Delta is PMC.

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：PMC）

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。

K252289Eva头皮冷却系统Stemtech Medical Devices Private LimitedK211526便携式头皮冷却系统Cooler Heads Care, Inc.K173032Paxman头皮冷却器Paxman Coolers LimitedK170871DigniCap头皮冷却系统Dignitana ABK163484Paxman头皮冷却器Paxman Coolers Limited

官方来源

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