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FDA 510(k)

Ethos 自动超声探头清洁消毒器，配备 AquaCide 清洁剂/高水平消毒剂和 QwikCheck 化学指示剂

K号: K230381 · 2023-06-07

申请人Cs Medical, LLC
决定日期2023-06-07
产品代码PSW
咨询委员会RA
决定实质等同

器械摘要

Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Cs Medical, LLC. It received FDA 510(k) clearance on 2023-06-07 under 510(k) number K230381. The device is classified under product code PSW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator?

Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator is a medical device that received FDA 510(k) clearance on 2023-06-07. The listed applicant is Cs Medical, LLC. The 510(k) number is K230381.

When did Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator receive FDA 510(k) clearance?

Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator received FDA 510(k) clearance on 2023-06-07, under 510(k) number K230381.

Who is the listed applicant for Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator?

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

What is the FDA product code for Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator?

The FDA product code for Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator is PSW.

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

列明Cs Medical, LLC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。

K233049TD 200® 自动化 TEE 探头消毒器，配备 TD-12® 高级消毒剂和 QwikCheck™ 化学指示剂K192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantK182891TEEClean(R) 自动化 TEE 探头清洁消毒器，配备 TEEZyme(R) 清洁剂和 TD-5(R) 或 TD-8(R) 高效消毒剂K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant

相关器械（代码：PSW）

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。

K233049TD 200® 自动化 TEE 探头消毒器，配备 TD-12® 高级消毒剂和 QwikCheck™ 化学指示剂Cs Medical, LLCK192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLCK182891TEEClean(R) 自动化 TEE 探头清洁消毒器，配备 TEEZyme(R) 清洁剂和 TD-5(R) 或 TD-8(R) 高效消毒剂Cs Medical, LLCK160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level DisinfectantCs Medical, LLC

官方来源

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