FDA 510(k)

GMR40

K番号: K171085 · 2017-05-11

申請者Neurologica Corporation, A Subsidiary OF

決定日2017-05-11

製品コードMQB

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

GMR40 is the device name listed in this FDA 510(k) record. The listed applicant is Neurologica Corporation, A Subsidiary OF. It received FDA 510(k) clearance on 2017-05-11 under 510(k) number K171085. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the GMR40?

GMR40 is a medical device that received FDA 510(k) clearance on 2017-05-11. The listed applicant is Neurologica Corporation, A Subsidiary OF. The 510(k) number is K171085.

When did GMR40 receive FDA 510(k) clearance?

GMR40 received FDA 510(k) clearance on 2017-05-11, under 510(k) number K171085.

Who is the listed applicant for GMR40?

The FDA 510(k) record lists Neurologica Corporation, A Subsidiary OF as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GMR40?

The FDA product code for GMR40 is MQB.

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医療機器の概要

よくある質問

関連機器（コード：MQB）

公式ソース