truFreeze 系統
K 號：K160273 · 2016-03-25
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器材摘要
truFreeze System is the device name listed in this FDA 510(k) record. The listed applicant is Csa Medial, Inc.. It received FDA 510(k) clearance on 2016-03-25 under 510(k) number K160273. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the truFreeze System?
truFreeze System is a medical device that received FDA 510(k) clearance on 2016-03-25. The listed applicant is Csa Medial, Inc.. The 510(k) number is K160273.
When did truFreeze System receive FDA 510(k) clearance?
truFreeze System received FDA 510(k) clearance on 2016-03-25, under 510(k) number K160273.
Who is the listed applicant for truFreeze System?
The FDA 510(k) record lists Csa Medial, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for truFreeze System?
The FDA product code for truFreeze System is GEH.
相關臨床試驗
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相關器械（代碼：GEH）
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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