FDA 510(k)

truFreeze 系統

K 號：K172041 · 2017-07-27

決定日期2017-07-27

產品代碼GEH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

truFreeze System is the device name listed in this FDA 510(k) record. The listed applicant is CSA Medical, Inc.. It received FDA 510(k) clearance on 2017-07-27 under 510(k) number K172041. 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 2017-07-27. The listed applicant is CSA Medical, Inc.. The 510(k) number is K172041.

When did truFreeze System receive FDA 510(k) clearance?

truFreeze System received FDA 510(k) clearance on 2017-07-27, under 510(k) number K172041.

Who is the listed applicant for truFreeze System?

The FDA 510(k) record lists CSA Medical, 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.

其他以 CSA Medical, Inc. 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。

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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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