FDA 510(k)

IQool™暖療系統

K 號：K180375 · 2018-05-18

決定日期2018-05-18

產品代碼DWJ

諮詢委員會履歷

決定相當於

器材摘要

The IQoolTM Warm System is the device name listed in this FDA 510(k) record. The listed applicant is Braincool AB. It received FDA 510(k) clearance on 2018-05-18 under 510(k) number K180375. 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 The IQoolTM Warm System?

The IQoolTM Warm System is a medical device that received FDA 510(k) clearance on 2018-05-18. The listed applicant is Braincool AB. The 510(k) number is K180375.

When did The IQoolTM Warm System receive FDA 510(k) clearance?

The IQoolTM Warm System received FDA 510(k) clearance on 2018-05-18, under 510(k) number K180375.

Who is the listed applicant for The IQoolTM Warm System?

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

What is the FDA product code for The IQoolTM Warm System?

The FDA product code for The IQoolTM Warm System is DWJ.

其他以 Braincool AB 為申請人之記錄

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K232844IQool™ 系統 K162523IQool 系統

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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