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FDA 510(k)

霧化器組合包

K 號:K192971 · 2021-07-08

決定日期2021-07-08
產品代碼CAF
諮詢委員會AN
決定相當於

器材摘要

Nebulizer Kit is the device name listed in this FDA 510(k) record. The listed applicant is Excellentcare Medical (Huizhou) , Ltd.. It received FDA 510(k) clearance on 2021-07-08 under 510(k) number K192971. 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 Nebulizer Kit?

Nebulizer Kit is a medical device that received FDA 510(k) clearance on 2021-07-08. The listed applicant is Excellentcare Medical (Huizhou) , Ltd.. The 510(k) number is K192971.

When did Nebulizer Kit receive FDA 510(k) clearance?

Nebulizer Kit received FDA 510(k) clearance on 2021-07-08, under 510(k) number K192971.

Who is the listed applicant for Nebulizer Kit?

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

What is the FDA product code for Nebulizer Kit?

The FDA product code for Nebulizer Kit is CAF.

相關臨床試驗

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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。

官方來源

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