FDA 510(k)

智能網狀霧化器

K 號：K171549 · 2018-08-31

申請人Qingdao Future Medical Technology Co., Ltd.

決定日期2018-08-31

產品代碼CAF

諮詢委員會AN

決定相當於

器材摘要

Intelligent Mesh Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Future Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-08-31 under 510(k) number K171549. 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 Intelligent Mesh Nebulizer?

Intelligent Mesh Nebulizer is a medical device that received FDA 510(k) clearance on 2018-08-31. The listed applicant is Qingdao Future Medical Technology Co., Ltd.. The 510(k) number is K171549.

When did Intelligent Mesh Nebulizer receive FDA 510(k) clearance?

Intelligent Mesh Nebulizer received FDA 510(k) clearance on 2018-08-31, under 510(k) number K171549.

Who is the listed applicant for Intelligent Mesh Nebulizer?

The FDA 510(k) record lists Qingdao Future Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Intelligent Mesh Nebulizer?

The FDA product code for Intelligent Mesh Nebulizer is CAF.

其他以 Qingdao Future Medical Technology Co., 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。

K251659網狀霧化器（H6）

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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