FDA 510(k)

GMR40

K 號：K171085 · 2017-05-11

申請人Neurologica Corporation, A Subsidiary OF

決定日期2017-05-11

產品代碼MQB

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：MQB）

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官方來源

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