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FDA 510(k)

PowerCube+系列 (PowerCube Body+)；PowerCube+系列 (PowerCube Diffusion+)；PowerCube+系列 (PowerCube Body+ / Diffusion+)

K号: K240706 · 2024-12-09

申请人Ganshorn Medizin Electronic GmbH
决定日期2024-12-09
产品代码JEH
咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。
决定实质等同

器械摘要

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) is the device name listed in this FDA 510(k) record. The listed applicant is Ganshorn Medizin Electronic GmbH. It received FDA 510(k) clearance on 2024-12-09 under 510(k) number K240706. The device is classified under product code JEH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) is a medical device that received FDA 510(k) clearance on 2024-12-09. The listed applicant is Ganshorn Medizin Electronic GmbH. The 510(k) number is K240706.

When did PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) receive FDA 510(k) clearance?

PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) received FDA 510(k) clearance on 2024-12-09, under 510(k) number K240706.

Who is the listed applicant for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

The FDA 510(k) record lists Ganshorn Medizin Electronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+)?

The FDA product code for PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) is JEH.

相关临床试验

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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

列明Ganshorn Medizin Electronic 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。

K160116SpiroScout

相关器械（代码：JEH）

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。

K223818Model 9160 VitaloQUBVitalograph Ireland, Ltd.

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