FDA 510(k)

eego放大器

K 號：K172312 · 2018-03-30

申請人Eemagine Medical Imaging Solutions GmbH

決定日期2018-03-30

產品代碼GWL

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

eego amplifiers is the device name listed in this FDA 510(k) record. The listed applicant is Eemagine Medical Imaging Solutions GmbH. It received FDA 510(k) clearance on 2018-03-30 under 510(k) number K172312. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the eego amplifiers?

eego amplifiers is a medical device that received FDA 510(k) clearance on 2018-03-30. The listed applicant is Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K172312.

When did eego amplifiers receive FDA 510(k) clearance?

eego amplifiers received FDA 510(k) clearance on 2018-03-30, under 510(k) number K172312.

Who is the listed applicant for eego amplifiers?

The FDA 510(k) record lists Eemagine Medical Imaging Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eego amplifiers?

The FDA product code for eego amplifiers is GWL.

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