冷療CS外科系統
K 號：K153489 · 2016-02-05
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器材摘要
Cryocare CS Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is Healthtronics. It received FDA 510(k) clearance on 2016-02-05 under 510(k) number K153489. 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 Cryocare CS Surgical System?
Cryocare CS Surgical System is a medical device that received FDA 510(k) clearance on 2016-02-05. The listed applicant is Healthtronics. The 510(k) number is K153489.
When did Cryocare CS Surgical System receive FDA 510(k) clearance?
Cryocare CS Surgical System received FDA 510(k) clearance on 2016-02-05, under 510(k) number K153489.
Who is the listed applicant for Cryocare CS Surgical System?
The FDA 510(k) record lists Healthtronics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cryocare CS Surgical System?
The FDA product code for Cryocare CS Surgical 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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