FDA 510(k)

EasyInstruments

K 號：K182013 · 2019-03-11

決定日期2019-03-11

產品代碼GEI

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

EasyInstruments is the device name listed in this FDA 510(k) record. The listed applicant is Agency For Medical Innovations GmbH. It received FDA 510(k) clearance on 2019-03-11 under 510(k) number K182013. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EasyInstruments?

EasyInstruments is a medical device that received FDA 510(k) clearance on 2019-03-11. The listed applicant is Agency For Medical Innovations GmbH. The 510(k) number is K182013.

When did EasyInstruments receive FDA 510(k) clearance?

EasyInstruments received FDA 510(k) clearance on 2019-03-11, under 510(k) number K182013.

Who is the listed applicant for EasyInstruments?

The FDA 510(k) record lists Agency For Medical Innovations GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EasyInstruments?

The FDA product code for EasyInstruments is GEI.

其他以 Agency For Medical Innovations GmbH 為申請人之記錄

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相關器械（代碼：GEI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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