FDA 510(k)

i-ED 環繞系統

K 號：K210638 · 2021-03-26

決定日期2021-03-26

產品代碼HCG

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

i-ED COIL System is the device name listed in this FDA 510(k) record. The listed applicant is Kaneka Medical America, LLC. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K210638. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the i-ED COIL System?

i-ED COIL System is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Kaneka Medical America, LLC. The 510(k) number is K210638.

When did i-ED COIL System receive FDA 510(k) clearance?

i-ED COIL System received FDA 510(k) clearance on 2021-03-26, under 510(k) number K210638.

Who is the listed applicant for i-ED COIL System?

The FDA 510(k) record lists Kaneka Medical America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-ED COIL System?

The FDA product code for i-ED COIL System is HCG.

其他以 Kaneka Medical America, LLC 為申請人之記錄

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K213166Thrombuster II 吸引針管

相關器械（代碼：HCG）

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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