FDA 510(k)

Mistral-Air 加熱單位

K 號：K171234 · 2017-05-26

申請人The Surgical Company International BV (As the 37company)

決定日期2017-05-26

產品代碼DWJ

諮詢委員會履歷

決定相當於

器材摘要

Mistral-Air Warming Unit is the device name listed in this FDA 510(k) record. The listed applicant is The Surgical Company International BV (As the 37company). It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K171234. 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 Mistral-Air Warming Unit?

Mistral-Air Warming Unit is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is The Surgical Company International BV (As the 37company). The 510(k) number is K171234.

When did Mistral-Air Warming Unit receive FDA 510(k) clearance?

Mistral-Air Warming Unit received FDA 510(k) clearance on 2017-05-26, under 510(k) number K171234.

Who is the listed applicant for Mistral-Air Warming Unit?

The FDA 510(k) record lists The Surgical Company International BV (As the 37company) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mistral-Air Warming Unit?

The FDA product code for Mistral-Air Warming Unit is DWJ.

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。

K262089一次性加熱毯Hangzhou Tappa Medical Technology Co., Ltd.K261437Mistral-Air® 加熱系統The Surgical Company International B.V., doing business as TSC Life K260278ThermAffyx™ 病患安全系統Stihler Electronic GmbH K260903熱粉紅墊加熱系統Xodus Medical, Inc.K252861加熱系統Hangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun 溫度管理系統 (型號 5000)Medivance, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：DWJ）

官方來源