FDA 510(k)

AIO 解决方案

K号: K191158 · 2019-08-06

决定日期2019-08-06

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

The AIO Solution is the device name listed in this FDA 510(k) record. The listed applicant is Orfit Industries NV. It received FDA 510(k) clearance on 2019-08-06 under 510(k) number K191158. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the The AIO Solution?

The AIO Solution is a medical device that received FDA 510(k) clearance on 2019-08-06. The listed applicant is Orfit Industries NV. The 510(k) number is K191158.

When did The AIO Solution receive FDA 510(k) clearance?

The AIO Solution received FDA 510(k) clearance on 2019-08-06, under 510(k) number K191158.

Who is the listed applicant for The AIO Solution?

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

What is the FDA product code for The AIO Solution?

The FDA product code for The AIO Solution is IYE.

列明Orfit Industries NV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。

K202068AIO 解决方案 3.0 K200282Orfit 悬挂式床 K171734HP PRO 定位装置 K162355Raycast MammoRx碳纤维乳腺板 K162862Raycast高精度肺板解决方案

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。