FDA 510(k)

truFreeze 快速AV噴霧組合包

K 號：K171522 · 2017-07-14

決定日期2017-07-14

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 Rapid AV Spray Kit 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 2017-07-14 under 510(k) number K171522. 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 Rapid AV Spray Kit?

truFreeze Rapid AV Spray Kit is a medical device that received FDA 510(k) clearance on 2017-07-14. The listed applicant is CSA Medical, Inc.. The 510(k) number is K171522.

When did truFreeze Rapid AV Spray Kit receive FDA 510(k) clearance?

truFreeze Rapid AV Spray Kit received FDA 510(k) clearance on 2017-07-14, under 510(k) number K171522.

Who is the listed applicant for truFreeze Rapid AV Spray Kit?

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 Rapid AV Spray Kit?

The FDA product code for truFreeze Rapid AV Spray Kit is GEH.

其他以 CSA Medical, Inc. 為申請人之記錄

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K201183迴流放射噴射電極管 K171626truFreeze 系統 K172041truFreeze 系統 K163244truFreeze 系統 K162695truFreeze 系統 K161557truFreeze 系統

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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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