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FDA 510(k)

Cenorin 610清洗-巴氏消毒器/高水平消毒器和Cenorin 610HT清洗-巴氏消毒器/高水平消毒器

K号: K183444 · 2019-09-09

申请人Cenorin, LLC
决定日期2019-09-09
产品代码LDS
咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同

器械摘要

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector is the device name listed in this FDA 510(k) record. The listed applicant is Cenorin, LLC. It received FDA 510(k) clearance on 2019-09-09 under 510(k) number K183444. The device is classified under product code LDS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector?

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector is a medical device that received FDA 510(k) clearance on 2019-09-09. The listed applicant is Cenorin, LLC. The 510(k) number is K183444.

When did Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector receive FDA 510(k) clearance?

Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector received FDA 510(k) clearance on 2019-09-09, under 510(k) number K183444.

Who is the listed applicant for Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector?

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

What is the FDA product code for Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector?

The FDA product code for Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector is LDS.

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

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