FDA 510(k)

食道冷卻裝置

K 號：K170009 · 2017-03-30

決定日期2017-03-30

產品代碼PLA

諮詢委員會履歷

決定相當於

器材摘要

Esophageal Cooling Device is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Cooling Therapy, LLC. It received FDA 510(k) clearance on 2017-03-30 under 510(k) number K170009. 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 Esophageal Cooling Device?

Esophageal Cooling Device is a medical device that received FDA 510(k) clearance on 2017-03-30. The listed applicant is Advanced Cooling Therapy, LLC. The 510(k) number is K170009.

When did Esophageal Cooling Device receive FDA 510(k) clearance?

Esophageal Cooling Device received FDA 510(k) clearance on 2017-03-30, under 510(k) number K170009.

Who is the listed applicant for Esophageal Cooling Device?

The FDA 510(k) record lists Advanced Cooling Therapy, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Esophageal Cooling Device?

The FDA product code for Esophageal Cooling Device is PLA.

其他以 Advanced Cooling Therapy, LLC 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。

K152450食道冷卻裝置

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 K172029EnsoETMAttune Medical K172493EnsoETMAttune Medical

官方來源

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