FDA 510(k)

第一級對流加熱器

K 號：K181699 · 2018-07-26

決定日期2018-07-26

產品代碼DWJ

諮詢委員會履歷

決定相當於

器材摘要

Level 1 Convective Warmer is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181699. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Level 1 Convective Warmer?

Level 1 Convective Warmer is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K181699.

When did Level 1 Convective Warmer receive FDA 510(k) clearance?

Level 1 Convective Warmer received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181699.

Who is the listed applicant for Level 1 Convective Warmer?

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

What is the FDA product code for Level 1 Convective Warmer?

The FDA product code for Level 1 Convective Warmer is DWJ.

其他以 Smiths Medical Asd, Inc. 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。

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相關器械（代碼：DWJ）

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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