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FDA 510(k)

BraiN20® (BraiN20)

K号: K253301 · 2026-06-27

申请人Time IS Brain, S.L.
决定日期2026-06-27
产品代码GWF
咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同

器械摘要

BraiN20® (BraiN20) is the device name listed in this FDA 510(k) record. The listed applicant is Time IS Brain, S.L.. It received FDA 510(k) clearance on 2026-06-27 under 510(k) number K253301. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BraiN20® (BraiN20)?

BraiN20® (BraiN20) is a medical device that received FDA 510(k) clearance on 2026-06-27. The listed applicant is Time IS Brain, S.L.. The 510(k) number is K253301.

When did BraiN20® (BraiN20) receive FDA 510(k) clearance?

BraiN20® (BraiN20) received FDA 510(k) clearance on 2026-06-27, under 510(k) number K253301.

Who is the listed applicant for BraiN20® (BraiN20)?

The FDA 510(k) record lists Time IS Brain, S.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BraiN20® (BraiN20)?

The FDA product code for BraiN20® (BraiN20) is GWF.

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：GWF）

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。

K263010ISIS 头箱，ISIS 神经刺激器，ISIS Xpert Plus，ISIS Xpert，ISIS Xpressinomed Medizintechnik GmbHK252842SafeOp 3：Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx NeuroscienceK234092SafeOp 3：Neural Informatix SysteemAlphatec Spine, Inc.

官方来源

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