FDA 510(k)

火飛蟲 T-2

K 號：K201131 · 2020-05-28

決定日期2020-05-28

產品代碼NGX

諮詢委員會PM

決定相當於

器材摘要

firefly T-2 is the device name listed in this FDA 510(k) record. The listed applicant is Firstkind Limited. It received FDA 510(k) clearance on 2020-05-28 under 510(k) number K201131. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the firefly T-2?

firefly T-2 is a medical device that received FDA 510(k) clearance on 2020-05-28. The listed applicant is Firstkind Limited. The 510(k) number is K201131.

When did firefly T-2 receive FDA 510(k) clearance?

firefly T-2 received FDA 510(k) clearance on 2020-05-28, under 510(k) number K201131.

Who is the listed applicant for firefly T-2?

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

What is the FDA product code for firefly T-2?

The FDA product code for firefly T-2 is NGX.

其他以 Firstkind Limited 為申請人之記錄

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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相關器械（代碼：NGX）

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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