FDA 510(k)

婴儿足跟保暖器（型号 24401）和 WarmGel 婴儿足跟保暖器（型号 20418）

K号: K151845 · 2016-03-18

决定日期2016-03-18

产品代码MPO

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is the device name listed in this FDA 510(k) record. The listed applicant is CooperSurgical, Inc.. It received FDA 510(k) clearance on 2016-03-18 under 510(k) number K151845. The device is classified under product code MPO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)?

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is a medical device that received FDA 510(k) clearance on 2016-03-18. The listed applicant is CooperSurgical, Inc.. The 510(k) number is K151845.

When did Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) receive FDA 510(k) clearance?

Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) received FDA 510(k) clearance on 2016-03-18, under 510(k) number K151845.

Who is the listed applicant for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)?

FDA 510(k)记录中列出CooperSurgical, Inc.为申请人。这本身并不足以确立设备制造商。

What is the FDA product code for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418)?

The FDA product code for Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) is MPO.

列明CooperSurgical, 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。

K261083华莱士® 吸引泵（WAPV1）；华莱士® 泵过滤器连接器（WFC）；华莱士® 真空连接套件（WVCK）K243799复杂腹裂胎儿修复：一项安全性和可行性试验 K250438CooperSurgical Milex® 子宫托 K223064ALLY II子宫定位系统™（UPS）K201086Advincula Delineator 宫腔操纵器 K200038Endosee System

查看所有 16 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。