FDA 510(k)

E-CUBE i7

K 號：K182594 · 2019-01-24

決定日期2019-01-24

產品代碼IYN

諮詢委員會RA

決定相當於

器材摘要

E-CUBE i7 is the device name listed in this FDA 510(k) record. The listed applicant is Alpinion Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2019-01-24 under 510(k) number K182594. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the E-CUBE i7?

E-CUBE i7 is a medical device that received FDA 510(k) clearance on 2019-01-24. The listed applicant is Alpinion Medical Systems Co., Ltd.. The 510(k) number is K182594.

When did E-CUBE i7 receive FDA 510(k) clearance?

E-CUBE i7 received FDA 510(k) clearance on 2019-01-24, under 510(k) number K182594.

Who is the listed applicant for E-CUBE i7?

The FDA 510(k) record lists Alpinion Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-CUBE i7?

The FDA product code for E-CUBE i7 is IYN.

其他以 Alpinion Medical Systems Co., Ltd. 為申請人之記錄

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。

K223564X-CUBE 50, X-CUBE 60 K221093X-CUBE 70, X-CUBE 90 K220857X-CUBE 50, X-CUBE 60 K213523X-CUBE i8, X-CUBE i9 K211299X-CUBE 70 K211300X-CUBE 90

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相關器械（代碼：IYN）

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。

官方來源

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