FDA 510(k)

EnsoETM

K 號：K172029 · 2018-01-05

決定日期2018-01-05

產品代碼PLA

諮詢委員會履歷

決定相當於

器材摘要

EnsoETM is the device name listed in this FDA 510(k) record. The listed applicant is Attune Medical. It received FDA 510(k) clearance on 2018-01-05 under 510(k) number K172029. The device is classified under product code PLA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EnsoETM?

EnsoETM is a medical device that received FDA 510(k) clearance on 2018-01-05. The listed applicant is Attune Medical. The 510(k) number is K172029.

When did EnsoETM receive FDA 510(k) clearance?

EnsoETM received FDA 510(k) clearance on 2018-01-05, under 510(k) number K172029.

Who is the listed applicant for EnsoETM?

The FDA 510(k) record lists Attune Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EnsoETM?

The FDA product code for EnsoETM is PLA.

其他以 Attune Medical 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。

K172493EnsoETM

相關器械（代碼：PLA）

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。

K250632Arctx 冷觸發導管組Arctx Medical K233357EsoCool 體溫調節針管Nuvaira, Inc.K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune Medical K172493EnsoETMAttune Medical K170009食道冷卻裝置Advanced Cooling Therapy, LLC

官方來源

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