FDA 510(k)

CUBEScan 生物醫療設備規範文本 CUBEScan BioCon-1100

K 號：K201995 · 2020-08-19

決定日期2020-08-19

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

CUBEScan BioCon-1100 is the device name listed in this FDA 510(k) record. The listed applicant is Mcube Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K201995. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CUBEScan BioCon-1100?

CUBEScan BioCon-1100 is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Mcube Technology Co., Ltd.. The 510(k) number is K201995.

When did CUBEScan BioCon-1100 receive FDA 510(k) clearance?

CUBEScan BioCon-1100 received FDA 510(k) clearance on 2020-08-19, under 510(k) number K201995.

Who is the listed applicant for CUBEScan BioCon-1100?

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

What is the FDA product code for CUBEScan BioCon-1100?

The FDA product code for CUBEScan BioCon-1100 is IYO.

其他以 Mcube Technology Co., Ltd. 為申請人之記錄

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相關器械（代碼：IYO）

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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