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FDA 510(k)

重新处理过的Masimo脉搏血氧仪（1859成人O2传感器），重新处理过的Masimo脉搏血氧仪（1860儿童O2传感器），重新处理过的Masimo脉搏血氧仪（1861婴儿O2传感器），重新处理过的Masimo脉搏血氧仪（1862成人O2传感器），重新处理过的Masimo脉搏血氧仪（2317成人O2传感器），重新处理过的Masimo脉搏血氧仪（2319婴儿O2传感器），重新处理过的Masimo脉搏血氧仪（2320成人O2传感器），重新处理过的Masimo脉搏血氧仪（2328婴儿O2传感器）

K号: K211140 · 2022-03-08

申请人Stryker Sustainability Solutions
决定日期2022-03-08
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

Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Sustainability Solutions. It received FDA 510(k) clearance on 2022-03-08 under 510(k) number K211140. 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 Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2?

Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 is a medical device that received FDA 510(k) clearance on 2022-03-08. The listed applicant is Stryker Sustainability Solutions. The 510(k) number is K211140.

When did Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 receive FDA 510(k) clearance?

Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 received FDA 510(k) clearance on 2022-03-08, under 510(k) number K211140.

Who is the listed applicant for Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2?

The FDA 510(k) record lists Stryker Sustainability Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2?

The FDA product code for Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 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Stryker Sustainability Solutions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。

K260636翻新 LigaSure XP Maryland 齿轮封口器/分隔器 无纳米涂层K250898再处理的HARMONIC 700剪（HAR723/再处理的HARMONIC 700，5mm直径剪，高级止血x 23cm）；再处理的HARMONIC 700剪（HAR736/再处理的HARMONIC 700，5mm直径剪，高级止血x 36cm）；再处理的HARMONIC 700剪（HAR745/再处理的HARMONIC 700，5mm直径剪，高级止血x 45cm）K241758重新处理过的RD SET Adt脉搏血氧仪传感器（4000）；重新处理过的RD SET Pdt脉搏血氧仪传感器（4001）；重新处理过的RD SET Inf脉搏血氧仪传感器（4002）；重新处理过的RD SET Adt脉搏血氧仪传感器（4003）K241606再处理的HARMONIC 1100剪，5mm直径，20cm长度（HAR1120）；再处理的HARMONIC 1100剪，5mm直径，36cm长度（HAR1136）K233471再处理的HARMONIC 1100剪，5mm直径，20cm长度（HAR1120）；再处理的HARMONIC 1100剪，5mm直径，36cm长度（HAR1136）K231621再处理ViewFlex Xtra ICE导管（D087031）

查看所有 25 个设备 →

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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