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FDA 510(k)

百分比氧气传感器

K号: K213933 · 2022-08-19

申请人Careox, LLC
决定日期2022-08-19
产品代码CCL
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

Percent Oxygen Sensors is the device name listed in this FDA 510(k) record. The listed applicant is Careox, LLC. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K213933. The device is classified under product code CCL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Percent Oxygen Sensors?

Percent Oxygen Sensors is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Careox, LLC. The 510(k) number is K213933.

When did Percent Oxygen Sensors receive FDA 510(k) clearance?

Percent Oxygen Sensors received FDA 510(k) clearance on 2022-08-19, under 510(k) number K213933.

Who is the listed applicant for Percent Oxygen Sensors?

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

What is the FDA product code for Percent Oxygen Sensors?

The FDA product code for Percent Oxygen Sensors is CCL.

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：CCL）

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。

K261389PRO2 Elite Plus 氧气分析仪（PRO2PLUS-1）Salter LabsK251245OxyMinder Pro（10310）Bio-Med Device, Inc.K250002Smart Check O2 (MA0236)Life Spark Medical, LLCK221734Maxtec MaxO2 ME+pMaxtec, LLCK213948OxyMinderBio-Med Devices, Inc.K173807Accu O2 氧气分析仪Precision Medical, Inc.

官方来源

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