FDA 510(k)

Care Cycle Connect应用程序

K号: K161411 · 2017-02-17

决定日期2017-02-17

产品代码MOD

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

Care Cycle Connect Application is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2017-02-17 under 510(k) number K161411. The device is classified under product code MOD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Care Cycle Connect Application?

Care Cycle Connect Application is a medical device that received FDA 510(k) clearance on 2017-02-17. The listed applicant is Respironics, Inc.. The 510(k) number is K161411.

When did Care Cycle Connect Application receive FDA 510(k) clearance?

Care Cycle Connect Application received FDA 510(k) clearance on 2017-02-17, under 510(k) number K161411.

Who is the listed applicant for Care Cycle Connect Application?

FDA 510(k)记录中列出Respironics, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Care Cycle Connect Application?

The FDA product code for Care Cycle Connect Application is MOD.

列明Respironics, 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。

K261262Altis 全脸面罩 K243394AF531 口鼻 SE 面罩 K231313Therapy Mask 3100 NC/SP K210844DreamWear 硅胶枕头面罩 K210386磁鼻罩 K202142Sleepware G3

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。