FDA 510(k)

SenSmart Model 8006CA可重复使用区域血氧饱和度传感器，SenSmart Model 8006PI一次性患者接口

K号: K190560 · 2019-05-02

决定日期2019-05-02

产品代码MUD

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决定实质等同

器械摘要

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface is the device name listed in this FDA 510(k) record. The listed applicant is Nonin Medical, Inc.. It received FDA 510(k) clearance on 2019-05-02 under 510(k) number K190560. The device is classified under product code MUD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface?

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface is a medical device that received FDA 510(k) clearance on 2019-05-02. The listed applicant is Nonin Medical, Inc.. The 510(k) number is K190560.

When did SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface receive FDA 510(k) clearance?

SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface received FDA 510(k) clearance on 2019-05-02, under 510(k) number K190560.

Who is the listed applicant for SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface?

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

What is the FDA product code for SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface?

The FDA product code for SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface is MUD.

列明Nonin Medical, Inc.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。

K211498与依维莫司相比，所有受试者中索利莫司与抗坏血酸的非劣效性试验 K192900H500 多功能血氧饱和度监测系统 K191403脉搏血氧仪 K172625可重复使用，指夹式非接触式医学CO-代谢氧饱和度传感器 K160231Model X-100C CO-Met™ 血氧饱和度系统 K160865型号6100C系列单患者使用，一次性脉搏血氧传感器（6100C系列：6100CA，6100CP，6100CI，6100CN），型号6101C系列单患者使用，一次性脉搏血氧传感器（6101C系列：6101CA，6101CP，6101CI，6101CN），型号6102C系列单患者使用，一次性脉搏血氧传感器（6102C系列：6102CA，6102CP，6102CI，6102CN），型号8100AA/8100AP可重复使用，指夹脉搏血氧传感器，型号8101AA/8101AP可重复使用，指夹脉搏血氧传感器

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