FDA 510(k)

Foley 带温度传感器的导管

K号: K200757 · 2020-10-15

决定日期2020-10-15

产品代码EYC

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Foley Catheter with Temperature Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 2020-10-15 under 510(k) number K200757. The device is classified under product code EYC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Foley Catheter with Temperature Sensor?

Foley Catheter with Temperature Sensor is a medical device that received FDA 510(k) clearance on 2020-10-15. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K200757.

When did Foley Catheter with Temperature Sensor receive FDA 510(k) clearance?

Foley Catheter with Temperature Sensor received FDA 510(k) clearance on 2020-10-15, under 510(k) number K200757.

Who is the listed applicant for Foley Catheter with Temperature Sensor?

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

What is the FDA product code for Foley Catheter with Temperature Sensor?

The FDA product code for Foley Catheter with Temperature Sensor is EYC.

列明Deroyal Industries, 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。

K250586Prospera Spectruum负压伤口治疗黑色泡沫套件和白色泡沫附件 K230233Prospera Spectruum负压伤口治疗系统 K200631DeRoyal 温度监测探头 K200319HYDRO-TEMP新生儿皮肤表面温度传感器，HYDRO-TEMP新生儿皮肤表面温度传感器带接口线 K193027食管听诊器 9 法寸，食管听诊器 12 法寸，食管听诊器 18 法寸，食管听诊器，24 法寸 K191425Hydro-Temp 新生儿皮肤温度探头盖

查看所有 10 个设备 →

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。

器械摘要

常见问题

相关临床试验

列明Deroyal Industries, Inc.为申报人的其他记录

官方来源