FDA 510(k)

明亮高流量

K 號：K200155 · 2020-11-30

決定日期2020-11-30

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Bright High Flow is the device name listed in this FDA 510(k) record. The listed applicant is Genoss Co., Ltd.. It received FDA 510(k) clearance on 2020-11-30 under 510(k) number K200155. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bright High Flow?

Bright High Flow is a medical device that received FDA 510(k) clearance on 2020-11-30. The listed applicant is Genoss Co., Ltd.. The 510(k) number is K200155.

When did Bright High Flow receive FDA 510(k) clearance?

Bright High Flow received FDA 510(k) clearance on 2020-11-30, under 510(k) number K200155.

Who is the listed applicant for Bright High Flow?

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

What is the FDA product code for Bright High Flow?

The FDA product code for Bright High Flow is EBF.

其他以 Genoss Co., Ltd. 為申請人之記錄

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相關器械（代碼：EBF）

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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官方來源

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