FDA 510(k)

MR 兼容抽吸套件

K 號：K181731 · 2018-11-20

決定日期2018-11-20

產品代碼GWG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

MR Compatible Aspiration Kit is the device name listed in this FDA 510(k) record. The listed applicant is Mri Interventions, Inc.. It received FDA 510(k) clearance on 2018-11-20 under 510(k) number K181731. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MR Compatible Aspiration Kit?

MR Compatible Aspiration Kit is a medical device that received FDA 510(k) clearance on 2018-11-20. The listed applicant is Mri Interventions, Inc.. The 510(k) number is K181731.

When did MR Compatible Aspiration Kit receive FDA 510(k) clearance?

MR Compatible Aspiration Kit received FDA 510(k) clearance on 2018-11-20, under 510(k) number K181731.

Who is the listed applicant for MR Compatible Aspiration Kit?

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

What is the FDA product code for MR Compatible Aspiration Kit?

The FDA product code for MR Compatible Aspiration Kit is GWG.

其他以 Mri Interventions, Inc. 為申請人之記錄

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相關器械（代碼：GWG）

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