FDA 510(k)

Magnus神经调节系统（MNS）带SAINT技术，型号1001K

K号: K220177 · 2022-09-01

决定日期2022-09-01

产品代码OBP

咨询委员会NE 请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。

决定实质等同

器械摘要

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is the device name listed in this FDA 510(k) record. The listed applicant is Magnus Medical, Inc.. It received FDA 510(k) clearance on 2022-09-01 under 510(k) number K220177. The device is classified under product code OBP. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is a medical device that received FDA 510(k) clearance on 2022-09-01. The listed applicant is Magnus Medical, Inc.. The 510(k) number is K220177.

When did Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K receive FDA 510(k) clearance?

Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K received FDA 510(k) clearance on 2022-09-01, under 510(k) number K220177.

Who is the listed applicant for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

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

What is the FDA product code for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K?

The FDA product code for Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K is OBP.

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。

Magnus神经调节系统（MNS）带SAINT技术，型号1001K

器械摘要

常见问题

相关临床试验

相关器械（代码：OBP）

官方来源