FDA 510(k)

IQool 系統

K 號：K162523 · 2017-05-03

決定日期2017-05-03

產品代碼NZE

諮詢委員會履歷

決定相當於

器材摘要

The IQool 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 2017-05-03 under 510(k) number K162523. The device is classified under product code NZE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the The IQool System?

The IQool System is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Braincool AB. The 510(k) number is K162523.

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

The IQool System received FDA 510(k) clearance on 2017-05-03, under 510(k) number K162523.

Who is the listed applicant for The IQool 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 IQool System?

The FDA product code for The IQool System is NZE.

其他以 Braincool AB 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。

K232844IQool™ 系統 K180375IQool™暖療系統

相關器械（代碼：NZE）

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。

K250979Thermogard HQ™ 體溫管理系統，Thermogard XP® 體溫管理系統（VitalTemp™ 大眾型墊）Zoll Circulation, Inc.K240933碳冷®系統Global Healthcare SG Sdn. Bhd K231182Thermogard HQ™ 體溫管理系統，Thermogard XP® 體溫管理系統Zoll Circulation, Inc.

官方來源

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