FDA 510(k)

生物根流0.5g，生物根流2g

K 號：K212283 · 2021-09-16

決定日期2021-09-16

產品代碼KIF

諮詢委員會DE

決定相當於

器材摘要

BioRoot Flow 0.5g, BioRoot Flow 2g is the device name listed in this FDA 510(k) record. The listed applicant is Septodont. It received FDA 510(k) clearance on 2021-09-16 under 510(k) number K212283. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BioRoot Flow 0.5g, BioRoot Flow 2g?

BioRoot Flow 0.5g, BioRoot Flow 2g is a medical device that received FDA 510(k) clearance on 2021-09-16. The listed applicant is Septodont. The 510(k) number is K212283.

When did BioRoot Flow 0.5g, BioRoot Flow 2g receive FDA 510(k) clearance?

BioRoot Flow 0.5g, BioRoot Flow 2g received FDA 510(k) clearance on 2021-09-16, under 510(k) number K212283.

Who is the listed applicant for BioRoot Flow 0.5g, BioRoot Flow 2g?

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

What is the FDA product code for BioRoot Flow 0.5g, BioRoot Flow 2g?

The FDA product code for BioRoot Flow 0.5g, BioRoot Flow 2g is KIF.

其他以 Septodont 為申請人之記錄

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相關器械（代碼：KIF）

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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