FDA 510(k)

AirLife 自動充填加濕腔室

K 號：K160764 · 2016-08-25

決定日期2016-08-25

產品代碼BTT

諮詢委員會AN

決定相當於

器材摘要

AirLife Autofill Humidification Chamber is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion 2200, Inc.. It received FDA 510(k) clearance on 2016-08-25 under 510(k) number K160764. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AirLife Autofill Humidification Chamber?

AirLife Autofill Humidification Chamber is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Carefusion 2200, Inc.. The 510(k) number is K160764.

When did AirLife Autofill Humidification Chamber receive FDA 510(k) clearance?

AirLife Autofill Humidification Chamber received FDA 510(k) clearance on 2016-08-25, under 510(k) number K160764.

Who is the listed applicant for AirLife Autofill Humidification Chamber?

The FDA 510(k) record lists Carefusion 2200, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirLife Autofill Humidification Chamber?

The FDA product code for AirLife Autofill Humidification Chamber is BTT.

其他以 Carefusion 2200, Inc. 為申請人之記錄

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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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