FDA 510(k)

AirLife Misty Finity 蒸發器

K 號：K153748 · 2017-05-17

決定日期2017-05-17

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

AirLife Misty Finity Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Care Fusion. It received FDA 510(k) clearance on 2017-05-17 under 510(k) number K153748. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AirLife Misty Finity Nebulizer?

AirLife Misty Finity Nebulizer is a medical device that received FDA 510(k) clearance on 2017-05-17. The listed applicant is Care Fusion. The 510(k) number is K153748.

When did AirLife Misty Finity Nebulizer receive FDA 510(k) clearance?

AirLife Misty Finity Nebulizer received FDA 510(k) clearance on 2017-05-17, under 510(k) number K153748.

Who is the listed applicant for AirLife Misty Finity Nebulizer?

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

What is the FDA product code for AirLife Misty Finity Nebulizer?

The FDA product code for AirLife Misty Finity Nebulizer is CAF.

其他以 Care Fusion 為申請人之記錄

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相關器械（代碼：CAF）

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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