FDA 510(k)

NuVision ICE 球囊電極导管

K 號：K201775 · 2021-03-05

決定日期2021-03-05

產品代碼OBJ

諮詢委員會履歷

決定相當於

器材摘要

NuVision ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nuvera Medical, Inc.. It received FDA 510(k) clearance on 2021-03-05 under 510(k) number K201775. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NuVision ICE Catheter?

NuVision ICE Catheter is a medical device that received FDA 510(k) clearance on 2021-03-05. The listed applicant is Nuvera Medical, Inc.. The 510(k) number is K201775.

When did NuVision ICE Catheter receive FDA 510(k) clearance?

NuVision ICE Catheter received FDA 510(k) clearance on 2021-03-05, under 510(k) number K201775.

Who is the listed applicant for NuVision ICE Catheter?

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

What is the FDA product code for NuVision ICE Catheter?

The FDA product code for NuVision ICE Catheter is OBJ.

相關器械（代碼：OBJ）

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。

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

器材摘要

常見問題

相關臨床試驗

相關器械（代碼：OBJ）

官方來源