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FDA 510(k)

1717FCC

K 號:K210985 · 2021-04-28

決定日期2021-04-28
產品代碼MQB
諮詢委員會RA
決定相當於

器材摘要

1717FCC is the device name listed in this FDA 510(k) record. The listed applicant is Rayence Co., Ltd.. It received FDA 510(k) clearance on 2021-04-28 under 510(k) number K210985. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 1717FCC?

1717FCC is a medical device that received FDA 510(k) clearance on 2021-04-28. The listed applicant is Rayence Co., Ltd.. The 510(k) number is K210985.

When did 1717FCC receive FDA 510(k) clearance?

1717FCC received FDA 510(k) clearance on 2021-04-28, under 510(k) number K210985.

Who is the listed applicant for 1717FCC?

FDA 510(k) 記錄將 Rayence Co., Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for 1717FCC?

The FDA product code for 1717FCC is MQB.

其他以 Rayence Co., Ltd. 為申請人之記錄

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相關器械(代碼:MQB)

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官方來源

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