FDA 510(k)

可重复使用SpO2传感器，一次性SpO2传感器

K号: K172981 · 2018-06-08

决定日期2018-06-08

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

Reusable SpO2 Sensors, Disposable SpO2 Sensors is the device name listed in this FDA 510(k) record. The listed applicant is APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K172981. 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 Reusable SpO2 Sensors, Disposable SpO2 Sensors?

Reusable SpO2 Sensors, Disposable SpO2 Sensors is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is APK Technology Co., Ltd.. The 510(k) number is K172981.

When did Reusable SpO2 Sensors, Disposable SpO2 Sensors receive FDA 510(k) clearance?

Reusable SpO2 Sensors, Disposable SpO2 Sensors received FDA 510(k) clearance on 2018-06-08, under 510(k) number K172981.

Who is the listed applicant for Reusable SpO2 Sensors, Disposable SpO2 Sensors?

The FDA 510(k) record lists APK Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reusable SpO2 Sensors, Disposable SpO2 Sensors?

The FDA product code for Reusable SpO2 Sensors, Disposable SpO2 Sensors is DQA.

列明APK Technology Co., Ltd.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。

K250425紫外线光疗设备 K170536心电图一次性导联线

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 GmbH K252655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 Systeme K260931Unimed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 Corporation K252805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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