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FDA 510(k)

Nellcor柔性SpO2传感器，Nellcor柔性SpO2传感器，小型，Nellcor柔性SpO2传感器，家庭护理（与上述相同传感器，包含家庭使用指南），Nellcor柔性SpO2传感器，小型，家庭护理（与上述相同传感器，包含家庭使用指南）

K号: K162014 · 2017-02-06

申请人Bluepoint Medical GmbH & Co. KG
决定日期2017-02-06
产品代码DQA
咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
决定实质等同

器械摘要

Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) is the device name listed in this FDA 510(k) record. The listed applicant is Bluepoint Medical GmbH & Co. KG. It received FDA 510(k) clearance on 2017-02-06 under 510(k) number K162014. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)?

Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) is a medical device that received FDA 510(k) clearance on 2017-02-06. The listed applicant is Bluepoint Medical GmbH & Co. KG. The 510(k) number is K162014.

When did Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) receive FDA 510(k) clearance?

Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) received FDA 510(k) clearance on 2017-02-06, under 510(k) number K162014.

Who is the listed applicant for Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)?

The FDA 510(k) record lists Bluepoint Medical GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)?

The FDA product code for Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) is DQA.

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Bluepoint Medical GmbH & Co. KG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。

K190824气道气体采样套装，一次性，成人/儿童，TPE，3m/10ft，气道气体采样套装，一次性，成人/儿童，TPE，2m/7ft，气道气体采样套装，一次性，婴儿，TPE，2m/7ft，带Luer连接器的气道适配器，成人/儿童

相关器械（代码：DQA）

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。

K252821可重复使用成人SpO2夹式传感器（3m）（M1196A）；可重复使用成人SpO2夹式传感器（0.9m）（M1196T）Philips Medizin Systeme Böblingen GmbHK252655脉搏血氧仪（PO-A2AO，PO-A2AT，PO-A3AO，PO-H1AO，PO-B1AO，PO-C5AO，PO-C5AT，PO-C6AO， PO-C6AT）Shenzhen Imdk Medical Technology Co., Ltd.K253887鼻翼SpO2传感器（989803205381）；鼻翼SpO2传感器（989803205391）；鼻翼Sp02传感器（989803205401）Philips Medizin SystemeK260931Unimed可重复使用指夹式SpO2传感器（U403-49R和U103-49R）Unimed Medical Supplies, Inc.K252448AViTA 脉搏血氧仪 (SP61)Avita CorporationK252805优威尔®指夹式脉搏血氧仪（YX105，YX106，YX110，YX310）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

官方来源

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