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FDA 510(k)

KT气道清除设备II（KT-3）；KT气道清除设备II（KT-5）

K号: K253001 · 2026-06-16

申请人Hunan Ruijiong Biotech Co., Ltd.
决定日期2026-06-16
产品代码NHJ
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

KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Ruijiong Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253001. The device is classified under product code NHJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)?

KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Hunan Ruijiong Biotech Co., Ltd.. The 510(k) number is K253001.

When did KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) receive FDA 510(k) clearance?

KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253001.

Who is the listed applicant for KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)?

The FDA 510(k) record lists Hunan Ruijiong Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5)?

The FDA product code for KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) is NHJ.

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：NHJ）

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。

K260604BiWaze 清洁系统Abmrc, LLCK242438ClearoBreas Medical ABK231728BiWaze 清洁系统Abmrc, LLCK213564BiWaze 清洁系统Abmrc, LLCK200988Maximus 系统Hill-Rom Services Pte, Ltd.K191912BiWaze 咳嗽Abmrc, LLC

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