FDA 510(k)

飛行60呼吸器

K 號：K143035 · 2016-03-30

決定日期2016-03-30

產品代碼CBK

諮詢委員會AN

決定相當於

器材摘要

Flight 60 Ventilator is the device name listed in this FDA 510(k) record. The listed applicant is Flight Medical Innovations , Ltd.. It received FDA 510(k) clearance on 2016-03-30 under 510(k) number K143035. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Flight 60 Ventilator?

Flight 60 Ventilator is a medical device that received FDA 510(k) clearance on 2016-03-30. The listed applicant is Flight Medical Innovations , Ltd.. The 510(k) number is K143035.

When did Flight 60 Ventilator receive FDA 510(k) clearance?

Flight 60 Ventilator received FDA 510(k) clearance on 2016-03-30, under 510(k) number K143035.

Who is the listed applicant for Flight 60 Ventilator?

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

What is the FDA product code for Flight 60 Ventilator?

The FDA product code for Flight 60 Ventilator is CBK.

其他以 Flight Medical Innovations , Ltd. 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。

K223120文東 VC2；文東 VC3

相關器械（代碼：CBK）

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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