碳冷®系統
K 號：K240933 · 2025-03-18
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器材摘要
CarbonCool® System is the device name listed in this FDA 510(k) record. The listed applicant is Global Healthcare SG Sdn. Bhd. It received FDA 510(k) clearance on 2025-03-18 under 510(k) number K240933. 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 CarbonCool® System?
CarbonCool® System is a medical device that received FDA 510(k) clearance on 2025-03-18. The listed applicant is Global Healthcare SG Sdn. Bhd. The 510(k) number is K240933.
When did CarbonCool® System receive FDA 510(k) clearance?
CarbonCool® System received FDA 510(k) clearance on 2025-03-18, under 510(k) number K240933.
Who is the listed applicant for CarbonCool® System?
The FDA 510(k) record lists Global Healthcare SG Sdn. Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CarbonCool® System?
The FDA product code for CarbonCool® System is NZE.
相關臨床試驗
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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。
官方來源
在 FDA 資料庫中查看 →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。
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