FDA 510(k)

MOBINEURO Alita 手术室 MRI 系统

K号: K223875 · 2023-03-20

申请人Sino Canada Health Engineering Research Institute (Hefei)

决定日期2023-03-20

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

MOBINEURO Alita Intraoperative MRI System is the device name listed in this FDA 510(k) record. The listed applicant is Sino Canada Health Engineering Research Institute (Hefei). It received FDA 510(k) clearance on 2023-03-20 under 510(k) number K223875. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MOBINEURO Alita Intraoperative MRI System?

MOBINEURO Alita Intraoperative MRI System is a medical device that received FDA 510(k) clearance on 2023-03-20. The listed applicant is Sino Canada Health Engineering Research Institute (Hefei). The 510(k) number is K223875.

When did MOBINEURO Alita Intraoperative MRI System receive FDA 510(k) clearance?

MOBINEURO Alita Intraoperative MRI System received FDA 510(k) clearance on 2023-03-20, under 510(k) number K223875.

Who is the listed applicant for MOBINEURO Alita Intraoperative MRI System?

The FDA 510(k) record lists Sino Canada Health Engineering Research Institute (Hefei) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOBINEURO Alita Intraoperative MRI System?

The FDA product code for MOBINEURO Alita Intraoperative MRI System is LNH.

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MOBINEURO Alita 手术室 MRI 系统

器械摘要

常见问题

相关临床试验

相关器械（代码：LNH）

官方来源